<ichicsr lang="en">
  <ichicsrmessageheader>
    <messagetype>ICSR</messagetype>
    <messageformatversion>2.1</messageformatversion>
    <messageformatrelease>1.0</messageformatrelease>
    <messagenumb>2012-08</messagenumb>
    <messagesenderidentifier>FDA CDER ODS</messagesenderidentifier>
    <messagereceiveridentifier>Public Use</messagereceiveridentifier>
    <messagedateformat>204</messagedateformat>
    <messagedate>2012092808:23:10</messagedate>
  </ichicsrmessageheader>
  <safetyreport>
    <safetyreportid>8555647-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16798944</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugbatchnumb>2C00893</drugbatchnumb>
        <drugdosagetext>1 INFUSION 15ML OF ORENCIA</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555648-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16540726</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugdosagetext>AZULFIDINE EN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugdosagetext>GRA</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>3 DOSES IV</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16807661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT SUBQ INJECTION 125MG/ML</medicinalproduct>
        <drugdosagetext>LAST DOSE ON 19JUL12</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555651-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555652-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE11922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555653-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014624</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRUXISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>090323</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555654-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014628</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>090323</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555655-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014629</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>065377</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OTITIS MEDIA ACUTE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555656-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA04444</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
        <drugauthorizationnumb>050587</drugauthorizationnumb>
        <drugdosagetext>500 MG, Q6H</drugdosagetext>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014630</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>078190</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014631</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugauthorizationnumb>074461</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLIVE OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555659-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014773</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugauthorizationnumb>077195</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555660-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PAR PHARMACEUTICAL, INC-2012SCPR004522</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070462</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555661-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PAR PHARMACEUTICAL, INC-2012SCPR004521</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070462</drugauthorizationnumb>
        <drugdosagetext>10 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>150 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>70462</drugauthorizationnumb>
        <drugdosagetext>40 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>225 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugdosagetext>20 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070462</drugauthorizationnumb>
        <drugdosagetext>30 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACAMPROSATE</medicinalproduct>
        <drugdosagetext>1332 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070462</drugauthorizationnumb>
        <drugdosagetext>40 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070462</drugauthorizationnumb>
        <drugdosagetext>40 MG, / DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555662-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014785</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENYLIN CHESTY COUGH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugauthorizationnumb>40415</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555663-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2012046962</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555664-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-AMGEN-HUNSP2012040767</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugdosagetext>5000 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugdosagetext>430 MG, ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>0.2 ML, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555665-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014786</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>072838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555666-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014787</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>076418</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>076418</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555667-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014787</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>078224</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>078224</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555668-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011000144</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.283</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCUVITE                            /01053801/</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugindication>GOITRE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D             /00944201/</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>325 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>416 MUG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110127</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTIC                         /00011701/</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>30 UNIT, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LONOX</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON M20</medicinalproduct>
        <drugdosagetext>20 MEQ, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>2 UNIT, ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555669-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2012046963</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555670-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0933880-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100408</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555671-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555672-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-MYLANLABS-2012S1014923</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>090970</drugauthorizationnumb>
        <drugdosagetext>30 MINUTES BEFORE MEALS FOR 4 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555673-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2012046899</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLFOX-4</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555674-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MYLANLABS-2012S1014971</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAP-HL                            /06436201/</medicinalproduct>
        <drugdosagetext>ENALAPRIL 20MG/HYDROCHLOROTHIAZIDE 12.5MG ONCE/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugdosagetext>35 MICROG/HOUR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NADROPARIN CALCIUM</medicinalproduct>
        <drugdosagetext>3800 IU/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2.5MG GLIBENCLAMIDE/400MG METFORMIN 3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>075986</drugauthorizationnumb>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555675-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MYLANLABS-2012S1014971</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2.5MG GLIBENCLAMIDE/400MG METFORMIN 3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NADROPARIN CALCIUM</medicinalproduct>
        <drugdosagetext>3800 IU/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugdosagetext>35 MICROG/HOUR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAP-HL                            /06436201/</medicinalproduct>
        <drugdosagetext>ENALAPRIL 20MG/HYDROCHLOROTHIAZIDE 12.5MG ONCE/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76276</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555676-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ABBOTT-12P-083-0955497-00</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPOGAMMAGLOBULINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555677-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-US372484</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555678-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-MYLANLABS-2012S1014973</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NADROPARIN CALCIUM</medicinalproduct>
        <drugdosagetext>5700 IU/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76276</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>GLIBENCLAMIDE 2.5MG/METFORMIN 400MG TWICE/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555679-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-009507513-1207SWE011548</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION SUSCEPTIBILITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010522</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>60 MICROGRAM, UNK</drugdosagetext>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010522</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555680-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2012S1014978</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>090911</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>090911</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555681-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555682-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-GRCSP2012046276</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
        <drugdosagetext>6 MG/KG, Q2WK</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIBRAMYCIN                         /00055702/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLFIRI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLFIRI</medicinalproduct>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555683-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2012S1014980</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>090911</drugauthorizationnumb>
        <drugdosagetext>100 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555684-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MYLANLABS-2012S1015026</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEUROTHOTONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE HYDROCHLORIDE 2MG TAB</medicinalproduct>
        <drugdosagetext>15 MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100 MG/D, LATER DESCRIBED AS 50MG TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>8MG/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>076288</drugauthorizationnumb>
        <drugdosagetext>6 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLEUROTHOTONUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>076288</drugauthorizationnumb>
        <drugdosagetext>4 MG/D, LATER DESCRIBED AS RECEIVING 2MG TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PLEUROTHOTONUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555685-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA04200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>500MG/50</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555686-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2011054882</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555687-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>090335</drugauthorizationnumb>
        <drugdosagetext>900 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555688-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MYLANLABS-2012S1015045</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOPAMINE DYSREGULATION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYCHLORIDE</medicinalproduct>
        <drugdosagetext>3MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugauthorizationnumb>75091</drugauthorizationnumb>
        <drugdosagetext>250MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROXIDOPA</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROXIDOPA</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIZZINESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555689-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER                     /01292501/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN                       /00097801/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555690-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1012201</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANOHEAL</medicinalproduct>
        <drugindication>ANAL FISSURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>076288</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>076288</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XENICAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEBEVERINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555691-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2012045176</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555692-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555693-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1009668</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>090868</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555694-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1009668</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>200463</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555695-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011035927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.005</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>500 MUG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110411</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555696-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555697-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555698-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR010309</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTANON 250</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCULAR WEAKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECA-DURABOLIN</medicinalproduct>
        <drugauthorizationnumb>13132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULAR WEAKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MYOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREATINE</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555699-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-SWESP2012047276</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070315</drugenddate>
        <drugtreatmentduration>647</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555700-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012047268</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRIL /BRA/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555701-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555702-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012029347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029716</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555703-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-TURSP2012046763</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555704-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555705-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555706-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555707-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010608</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>400 MG, 5 DAYS/7 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM OXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555708-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-058652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555709-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UBIDECARENONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555710-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555711-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POTENTIATING DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXACILLIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555712-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TATRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555713-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PAR PHARMACEUTICAL, INC-2012SCPR004525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>077494</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555714-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555715-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMAVERT</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555716-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555717-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555718-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>10 MUG/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555719-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BAYER-2012-069315</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>METRORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555720-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555721-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA009883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHYLOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555724-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555725-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPARTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555726-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK, HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugdosagetext>30 MINS BEFORE MEALS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UP TO 4 TIMES DAILY WHEN REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1-6 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555727-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>6.25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555728-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011402</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEARFULNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, 40 MG</drugdosagetext>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555729-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2012040263</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>500 MUG, 2 INJECTIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555730-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021463</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>859</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555731-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2012037094</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555732-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555733-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009996</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINDOLOL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICORANDIL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555734-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA009932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM TREMENS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555735-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>FOR UP TO THREE YEARS</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555736-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-NO-1207S-0799</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11652410,11673010</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMATURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555737-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2012043152</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG/TIME</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555738-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP017111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>68 MG/3 YEAR IMPLANT</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555739-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555740-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CM-MSD-1207CMR011628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MECTIZAN</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugdosagetext>4 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONCHOCERCIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555741-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150MCG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555742-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA011369</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VASCULAR PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555743-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-RANBAXY-2012RR-58455</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERLACTACIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600MG EVEY 72 HOURS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>600 MG EVERY 12 HOURS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BARNIDIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugdosagetext>SHE WAS VARYING HER DOSAGES  FROM 600MG EVERY 24 HOURS TO 600MG EVERY 36 HOURS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>076989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555744-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58242</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINCHOCAINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GERMOLOIDS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUCIDINE CAP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOTHIEPIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555745-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58416</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>065109</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLECYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555746-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58419</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065382</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 A?G, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555747-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58431</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugauthorizationnumb>065061</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555748-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58405</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>8X50MG ON DAY 1 AND 6X50MG ON DAY 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, 4/ AS NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555749-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-56396</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555750-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GE HEALTHCARE MEDICAL DIAGNOSTICS-VISP-NO-1207S-0319</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISIPAQUE</medicinalproduct>
        <drugbatchnumb>11450763</drugbatchnumb>
        <drugauthorizationnumb>020351</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555751-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDCT2012034756</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTROCYTOMA MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
        <drugtreatmentduration>1602</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555752-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555753-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 19-9 INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>50MG/1000MG,TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555754-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555755-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA011370</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE V HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555756-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA04525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555757-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555758-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>850 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555759-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2012BI010572</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555760-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555761-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555762-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555763-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BIOGENIDEC-2012BI023593</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555764-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI024440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555765-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2012BI026546</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555766-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555767-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555768-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555769-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555770-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLINE BITARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071207</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESVERATROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM MAGNESIUM ASPARTAT</medicinalproduct>
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        <drugstartdate>20070803</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
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        <drugstartdate>20110927</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q-10</medicinalproduct>
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        <drugstartdate>20111128</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENNSAID TOPICAL SOLUTION 1.5%W/W</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>8555771-X</safetyreportid>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20110112</drugstartdate>
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  <safetyreport>
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        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555788-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555789-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555790-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026835</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555791-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555792-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555793-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555794-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555795-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555796-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555797-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32167</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555798-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R32011</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555799-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI007821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAND SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555800-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555801-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI014779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555802-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI025451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555803-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI033030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUSTER HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERONS (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugindication>CLUSTER HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555804-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI012677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555805-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI015492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555806-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI019581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555807-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI020131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555808-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021408</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555809-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555810-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI022619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555811-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI023270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025327</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE PILLS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (NOS)</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODY'S POWDER</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555815-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555816-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555817-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555818-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090827</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555819-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555820-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555821-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555822-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555823-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555824-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110304</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555826-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555831-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555832-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555833-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555834-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026794</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555835-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555836-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555837-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555838-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555839-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555840-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555841-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555842-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555843-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
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        <drugenddate>20091125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555845-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555846-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080331</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>8555847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>8555848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100702</drugstartdate>
      </drug>
    </patient>
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    <safetyreportid>8555849-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555851-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555852-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>8555853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027478</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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        <drugstartdate>20080206</drugstartdate>
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        <drugenddate>20080815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
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    <safetyreportid>8555858-1</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555863-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555864-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555865-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555866-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555867-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555868-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555869-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091002</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555870-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555871-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555872-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111003</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555873-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555874-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555875-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555876-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555877-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555878-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555879-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555880-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555881-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555882-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555883-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555884-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555885-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555886-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555887-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027880</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111104</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555888-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555889-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCOTIC</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHETAMINES</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555890-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028035</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100524</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555891-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI029530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555892-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2005BI003773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050905</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555893-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555894-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI024693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555895-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI024710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555896-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R32015</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R32015</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555897-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555898-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555899-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110928</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555900-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555901-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555902-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R32015</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555903-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555904-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SEXUAL AROUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555905-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555906-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555907-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555908-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555909-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555910-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555911-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555912-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555913-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P41010</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555914-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (NOS)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555915-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020909</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555916-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555917-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555918-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555919-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555920-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555921-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555922-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555923-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555924-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555925-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555926-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555927-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555928-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555929-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555930-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555931-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555932-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027209</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060914</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555933-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555934-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555935-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555936-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555937-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555938-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555939-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555940-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555941-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555942-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MECHANICAL URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070917</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555943-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555944-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555945-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-NO-1207S-0814</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555946-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-068063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DEPLOYMENT ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555947-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>1 TABLET, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555948-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111119</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555949-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>1IRJ605</drugbatchnumb>
        <drugdosagetext>0.4 ML, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555950-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GE HEALTHCARE MEDICAL DIAGNOSTICS-MSTR-NO-1206S-0040</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METASTRON</medicinalproduct>
        <drugauthorizationnumb>020134</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555951-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555952-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAMPBELL DE MORGAN SPOTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555953-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET XR</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>50/1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555954-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP022027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH IMPLANT CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>27 MG, UNK</drugdosagetext>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555955-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58414</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555956-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16238BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555957-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555958-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-009507513-1207TUR012440</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555959-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOSOMATIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAXAGLIPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>21995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555960-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555961-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58593</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>075132</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555962-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP034899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>87921</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555963-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555964-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA011853</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020830</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555965-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16240BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555966-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA009773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555967-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>0.5, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555968-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA004835</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>21995</drugauthorizationnumb>
        <drugdosagetext>700 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>7 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>7 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPANOR</medicinalproduct>
        <drugdosagetext>700 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>7 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>28 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555969-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-009507513-1207DEU010705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111222</drugenddate>
        <drugtreatmentduration>144</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111222</drugenddate>
        <drugtreatmentduration>144</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENFOTIAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MERCAZOLE TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GOITRE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG PEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555970-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555971-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP024755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555972-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201026767NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAT INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE W/ ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INCREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIPEX-P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>91628A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>821</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFACLOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VARICOSE VEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>6</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555973-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2012-03806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TUBERSOL</medicinalproduct>
        <drugbatchnumb>C3764A</drugbatchnumb>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>TUBERCULIN TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555974-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SP-2012-07163</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555975-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100903</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201026915NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERMETHRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
        <drugtreatmentduration>1552</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555976-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101220</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201027504NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CHOLESTEROLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
        <drugtreatmentduration>426</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN FE 1/20</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555977-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2012046475</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555978-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201027512NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UNEVALUABLE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555979-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCELERATED HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAFUTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555980-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555981-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028705NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>142.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CHOLESTEROLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1096</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D [FEXOFENADINE HYDROCHLORIDE,PSEUDOEPHEDRINE HYDROCHLORID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASERETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
        <drugtreatmentduration>1400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555982-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201029476NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.182</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCHOLECYSTIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>150 MG 24 HR TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EX-TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>06 MG-1 MG CAP DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>06 MG-1 MG CAP DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRONOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090715</drugenddate>
        <drugtreatmentduration>3074</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555983-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101227</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201028694NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MG, CONT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020909</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555984-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555985-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>802618</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555986-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555987-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-009507513-2011SP059354</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEBETINA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555988-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555989-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP032071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>268635</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
        <drugtreatmentduration>1275</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555990-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-009507513-1206USA01264</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TRAUMATIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555991-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP016562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugbatchnumb>110339</drugbatchnumb>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
        <drugdosagetext>2 PUFF</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555992-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555993-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP034066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555997-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUCT2012042904</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>117</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLAC                             /00372302/</medicinalproduct>
        <drugdosagetext>75 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>850 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555998-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012045199</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSAGE, EVERY 15 DAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8555999-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030660NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.727</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>426</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556002-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>923191</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556003-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556004-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA009764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556005-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CAPSULE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556006-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012046738</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556007-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556008-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.3 MICROGRAM PER KILOGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GLIOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556009-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>650 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>1-6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556010-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556011-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-GRCSP2012047411</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556015-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN GERM CELL TERATOMA BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556016-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556017-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16430BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201920A,11C3222</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556026-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP035628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556027-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA003121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>240</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556028-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556029-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556030-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556031-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA000301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>68 MG, UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556032-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556033-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN000172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>DIVIDED DOSE FREQUENCY U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>DIVIDED DOSE FREQUENCY U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugdosagetext>DIVIDED DOSE FREQUENCY U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100711</drugenddate>
        <drugtreatmentduration>3601</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556037-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201032524NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>147.85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>TABLETS 28'S</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050905</drugenddate>
        <drugtreatmentduration>880</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISMUTH SUBSALICYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMENTARY TRACT AND METABOLISM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG, OM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556038-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201032652NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>1217</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHINYLESTRADIOL W/NORGESTIMATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556044-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-2012SP036861</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOCEPREVIR</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 ?G, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ASPART, BIPHASIC ISOPHANE [INJECTION]</medicinalproduct>
        <drugdosagetext>32 IU, TID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1000</drugdosagetext>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556045-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP026361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>848133</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN (+) DIPHENHYDRAMINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556046-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201032681NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556047-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100917</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030887NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>400 MG, Q4HR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080121</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1000 UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKA SELTZER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>ON 13-OCT-2006 SHE WAS ON YASMIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>UNK UNK, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556049-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350675USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugbatchnumb>PA226A</drugbatchnumb>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556050-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACCORD-012295</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>201335</drugauthorizationnumb>
        <drugdosagetext>FOR MORE THAN 3 YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>FOR MORE THAN 3 YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>0.5. FOR MORE THAN 3 YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>FOR MORE THAN 3 YEARS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BENIDIPINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>FOR MORE THAN 3 YEARS.</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556051-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ACCORD-014182</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROTISING FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>201195</drugauthorizationnumb>
        <drugdosagetext>CYCLE 2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556052-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>80/4.5 MCG, TWO PUFFS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>019558</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>80/4.5 MCG, ONE PUFF, AT NIGHT</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556053-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201033649NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020526</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM 1/35</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERIDIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556058-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351186USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556059-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556060-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556061-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556062-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556063-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-105350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.692</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH INJECTABLE CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE DELIVERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110630</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556064-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-054926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556065-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-046873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.288</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00DKW</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556066-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00E3A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00E3A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556067-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201033753NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN XR</medicinalproduct>
        <drugdosagetext>2 TAB DOR 10 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BREAST TENDERNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556069-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201033840NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>669</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>3287</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>669</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>669</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556075-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120711539</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556076-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120711459</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556077-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120713559</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556078-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556079-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120707717</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>CAB4W00</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556080-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120611582</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556081-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20120711268</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556082-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120700168</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALOLACTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIHEXYPHENIDYL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556083-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120413991</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>DOSAGE AND FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugdosagetext>DOSAGE AND FREQUENCY UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556084-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120308797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556085-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20120713907</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556086-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120713930</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556091-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034016NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VAGINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>821</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VAGINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VAGINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080815</drugenddate>
        <drugtreatmentduration>821</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556092-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA042316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>10-30IU/DAY</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>3-6 RDA/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>RECEIVED INSULIN FOR THE ENTIRE PERIOD OF PREGNANCY. START DATE FROM 2006. DOSE 12 TO 35 IU/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>2PILLS/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2 TABLETS COD LIVER OIL/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556093-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120401247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556094-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556095-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120605006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556096-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712816</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556097-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712905</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLAFREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTIFOAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPTAZ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALTEPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAVOL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556098-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>PA647A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>PA647A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556099-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120609911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556100-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOBACCO POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>LH941</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556101-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-AVENTIS-2012SA052709</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DEVICE THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556103-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-JNJFOC-20120113016</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556104-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556105-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120404628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORGESTIMATE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>N50-270</drugbatchnumb>
        <drugauthorizationnumb>019697</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120302</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556106-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20120713482</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO EVRA</medicinalproduct>
        <drugauthorizationnumb>021180</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556107-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120704320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugdosagetext>3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugdosagetext>3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>7.5/325  7.5MG ONCE DAILY AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/325MG DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556108-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120704481</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugauthorizationnumb>200533</drugauthorizationnumb>
        <drugdosagetext>TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556109-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120704424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 MG 3 TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>200533</drugauthorizationnumb>
        <drugdosagetext>50 MG 3 TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556111-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE:70 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556112-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120408629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>2 SPRAYS EACH NOSTRIL</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556113-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120210656</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556114-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120711495</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556115-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOASGE: SLIDING SCALE DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556116-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200920703NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBOTIC AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060522</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556117-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200921527NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO-CEPT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHEGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PEPTIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATO DE RINGER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090115</drugenddate>
        <drugtreatmentduration>1521</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGEN</medicinalproduct>
        <drugdosagetext>THESE DATES OF TREATMENT WERE PROVIDED BY DOCTOR'S NOTE.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE METHYLSULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOXITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1156</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>VAIROUS. SINCE 1984</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDETTE-21</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556122-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>6 MUG/KG, QWK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556123-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-GENZYME-FABR-1002529</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>126</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMPRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPENA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.5 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZOLONES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556125-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1003102</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091223</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090809</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>C8034NA</drugbatchnumb>
        <drugdosagetext>165 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090808</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090808</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091111</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090928</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090906</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090902</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090814</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556126-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENZYME-CAMP-1002347</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABCAMPATH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MG, UNK (MONOTHERAPY)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556127-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-CLOF-1002239</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>18 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMSACRINE</medicinalproduct>
        <drugdosagetext>210 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>3600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556128-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA012736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21629</drugauthorizationnumb>
        <drugdosagetext>6 UNITS WITH BREAKFAST IN AM, 6 UNITS WITH LUNCH AND 6 UNITS WITH DINNER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>24 U IN AM AND 28 U IN PMI</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556129-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351180USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556130-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00D00</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556131-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034059NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), ,</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG (DAILY DOSE), TID,</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080808</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/325 MG 1-2 TABS Q6H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080808</drugenddate>
        <drugtreatmentduration>1096</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG (DAILY DOSE), ,</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080615</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>375 MG (DAILY DOSE), ,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>Q8H</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080808</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 PUFFS</drugdosagetext>
        <drugindication>PAINFUL RESPIRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080315</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ PROPOXYPHENE HCL</medicinalproduct>
        <drugdosagetext>650 TABS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080807</drugenddate>
        <drugtreatmentduration>151</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>40 MG (DAILY DOSE), QD,</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG (DAILY DOSE), ,</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090615</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>650 TABS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>1 PUFF</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080808</drugenddate>
        <drugtreatmentduration>487</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556132-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556134-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA029821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21629</drugauthorizationnumb>
        <drugdosagetext>SLIDING SCALE: 1 TO 5 UNITS 3-4 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556135-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA037311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugbatchnumb>1F315A</drugbatchnumb>
        <drugauthorizationnumb>021629</drugauthorizationnumb>
        <drugdosagetext>PUMP</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556136-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG, TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG, TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 U, CAP</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>LIQ</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 CR TAB</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556137-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200928784NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.091</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTROBAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>700</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAL VACCINES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE W/ CODEINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556141-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556142-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034292NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556143-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034367NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.506</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>92411A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556144-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ACCORD-014198</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>078155</drugauthorizationnumb>
        <drugdosagetext>40 MIXED TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>40 DF, (MIXED TABLET) WHICH INCLUDED CLOZARIL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>793</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556146-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1207S-0818</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556147-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NG-RANBAXY-2012RR-57845</companynumb>
    <primarysource>
      <reportercountry>NIGERIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>075944</drugauthorizationnumb>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556148-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-RANBAXY-2012RR-58591</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556149-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-047769</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556150-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201034707NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN PAPILLOMA VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU001VK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G (DAILY DOSE), , INTRA-UTERINE</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556151-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-BAYER-2012-075765</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556152-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200930294NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 TAB/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041215</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLESSA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556153-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011041</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556154-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA053663</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE/CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556157-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2012US-58230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>200794</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROBAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556158-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16424BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITONIN SALMON</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556159-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1207S-0825</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556160-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16248BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201741,11C2203</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201741,11C2203</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556161-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFUSION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>022023</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556162-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>022023</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556163-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556164-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA001291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556165-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351189USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556166-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011014122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556167-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>022023</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556168-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACCORD-008452</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>COLON CANCER STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>COLON CANCER STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>COLON CANCER STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugindication>COLON CANCER STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>079068</drugauthorizationnumb>
        <drugindication>COLON CANCER STAGE IV</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556169-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU0098Z</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556170-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00B8L</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556171-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556172-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1207S-0826</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556173-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EHH</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556174-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00DGG</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556175-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556176-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1207S-0827</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556177-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARIANT CREUTZFELDT-JAKOB DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556179-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1207S-0828</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556180-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA052449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>183</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556181-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1207S-0829</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11626693</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556182-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SHIRE-ALL1-2012-03652</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019815</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>150 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROCEDURAL VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>1 DF, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>75 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID NOS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>19815</drugauthorizationnumb>
        <drugdosagetext>15 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>1 DF, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROCEDURAL VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>1 DF, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LARGACTIL                          /00011901/</medicinalproduct>
        <drugdosagetext>250 DF, UNKNOWN (150-250 DF 4% DROPS FOR ORAL USE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556185-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556186-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER PILLS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556187-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556188-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556189-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.331</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>NAA0D9W</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556190-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556191-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556192-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP032498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556193-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>905088</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556194-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA001111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZASITE</medicinalproduct>
        <drugauthorizationnumb>050810</drugauthorizationnumb>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556195-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA005783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556198-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2012SP002126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>208</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA /01400501/</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATUDA</medicinalproduct>
        <drugauthorizationnumb>200603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA /01400501/</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>PARANOIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIOIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>MOOD SWINGS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATUDA</medicinalproduct>
        <drugauthorizationnumb>200603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATUDA</medicinalproduct>
        <drugauthorizationnumb>200603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATUDA</medicinalproduct>
        <drugauthorizationnumb>200603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556199-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-SANOFI-AVENTIS-2012SA047346</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID/MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID/MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556200-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-UCBSA-062667</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE 400</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>FORTNIGHTLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556201-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351200USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>33802799A</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556203-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556204-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556205-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556206-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556207-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556208-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556209-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556210-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-072829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556211-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>6 DF IN A 24 HR PERIOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556212-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556213-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-006071</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOLEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOLEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOLEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TSUMURA JUZENTAIHOTO EXTRACT GRANULES FOR ETHICAL USE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556214-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-005682</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556215-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351157USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugbatchnumb>RC30711</drugbatchnumb>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556216-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7059432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002351</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556217-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7045333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556218-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7051251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556219-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7149989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003689</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556220-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556221-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16249BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556222-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16422BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>106723A,11C3209</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>9 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556223-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7048714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EIGHT HOUR TYLENOL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556224-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002717</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556225-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556226-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7044992</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556227-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7043365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556228-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7149988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556229-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7137580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003353</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003353</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556230-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENZYME-CERZ-1002585</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556231-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201202004364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.48</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>1000 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556235-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-2011-003027</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>KIDNEY INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556236-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>FOR 2 MONTHS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556237-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>ADMINISTERED OVER 3 TO 5 MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAY 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>DAY 1-5, CAPPED 1.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556238-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>FOR EVERY 6 MONTHS FOR 2 YEARS OR TILL PROGRESSIVE DISEASE (MAINTENANCE)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.0 TO 1.6 MG/M2 ON DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>FOR EVERY 6 MONTHS FOR 2 YEARS OR TILL PROGRESSIVE DISEASE (MAINTENANCE)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>MAINTENANCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>MAINTENANCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAY 1 NOT TO EXCEED 1.5 MG FROM LEVEL 1 AND 2 AND NOT TO EXCEED 2 MG FOR LEVEL 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAY 1 NOT TO EXCEED 1.5 MG FROM LEVEL 1 AND 2 AND NOT TO EXCEED 2 MG FOR LEVEL 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.0 TO 1.6 MG/M2 ON DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.0 TO 1.6 MG/M2 ON DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>MAINTENANCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.0 TO 1.6 MG/M2 ON DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>FOR EVERY 6 MONTHS FOR 2 YEARS OR TILL PROGRESSIVE DISEASE (MAINTENANCE)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAY 1 NOT TO EXCEED 1.5 MG FROM LEVEL 1 AND 2 AND NOT TO EXCEED 2 MG FOR LEVEL 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>MAINTENANCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>FOR EVERY 6 MONTHS FOR 2 YEARS OR TILL PROGRESSIVE DISEASE (MAINTENANCE)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>MAINTENANCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAY 1 NOT TO EXCEED 1.5 MG FROM LEVEL 1 AND 2 AND NOT TO EXCEED 2 MG FOR LEVEL 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAY 1 NOT TO EXCEED 1.5 MG FROM LEVEL 1 AND 2 AND NOT TO EXCEED 2 MG FOR LEVEL 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOCYTIC LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>FOR EVERY 6 MONTHS FOR 2 YEARS OR TILL PROGRESSIVE DISEASE (MAINTENANCE)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>FOR EVERY 6 MONTHS FOR 2 YEARS OR TILL PROGRESSIVE DISEASE (MAINTENANCE)</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>MAINTENANCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.0 TO 1.6 MG/M2 ON DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>WALDENSTROM'S MACROGLOBULINAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.0 TO 1.6 MG/M2 ON DAYS 1 AND 8</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAY 1 NOT TO EXCEED 1.5 MG FROM LEVEL 1 AND 2 AND NOT TO EXCEED 2 MG FOR LEVEL 3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>ON DAYS 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556240-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120712891</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA REFRACTORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIRARUBICIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLADRIBINE</medicinalproduct>
        <drugauthorizationnumb>20229</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556241-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7043521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556242-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7149991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556243-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010950</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZATOL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556244-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010915</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUZENTAIHOTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556245-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-002736</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556246-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010990</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556247-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-006756</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL COMBINATION GRANULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL COMBINATION GRANULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556248-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556249-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7107547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002502,AU002836</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002502,AU002836</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556250-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0960349-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556252-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugauthorizationnumb>011795</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556253-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugauthorizationnumb>018422</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALAN SR</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556254-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRING</medicinalproduct>
        <drugauthorizationnumb>020472</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556255-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556256-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556257-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556258-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>E00133</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556259-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.143</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>F76556</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556260-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG IN MORNING AND 1000 MG AT NIGHT</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG AT NIGHT AND 20 MG IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG IN MORNING AND 80 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>40 MG IN MORNING AND 80 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 OR 200 MG DAILY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556261-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556262-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556263-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugauthorizationnumb>021375</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556264-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD CRAVING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556265-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012142065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>B10561330</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556266-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012127357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>12.245</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S ADVIL COLD</medicinalproduct>
        <drugauthorizationnumb>021373</drugauthorizationnumb>
        <drugindication>TONSILLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S ADVIL COLD</medicinalproduct>
        <drugbatchnumb>F81028</drugbatchnumb>
        <drugauthorizationnumb>021373</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556267-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012164821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556268-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556269-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012171924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556270-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556271-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012151070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>TWO CAPSULES OF 25MG, 4 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG, ONCE EVERY TWO WEEK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN JAW</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556272-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE</medicinalproduct>
        <drugdosagetext>15 MG, 3X/DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556273-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012172925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT PRODUCT STORAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556274-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012129268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556275-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012135272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556276-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANTIN</medicinalproduct>
        <drugauthorizationnumb>050675</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556277-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012161110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556278-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012063508</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>37.5 + 75 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugdosagetext>17 G, DAILY</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>050533</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugindication>ECHOGRAPHY ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>ECHOCARDIOGRAM ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugindication>OESOPHAGEAL SPASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>37.5 MG, DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
        <drugtreatmentduration>175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>ARTERIOSPASM CORONARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556280-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012161224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>202080</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>18565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556281-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012142467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLEOCIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>0BTU8</drugbatchnumb>
        <drugauthorizationnumb>050767</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556282-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012136564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugbatchnumb>F67691</drugbatchnumb>
        <drugauthorizationnumb>020303</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY (0.625/2.5 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTMENOPAUSE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPHASE 14/14</medicinalproduct>
        <drugbatchnumb>F08666S2</drugbatchnumb>
        <drugauthorizationnumb>020303</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY (0.625/5 MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTMENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556283-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012163810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556284-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012142392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHANTOM PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>100MG DAILY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V120172</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>TWO CAPSULES OF 50MG IN THE MORNING, AFTERNOON AND THREE CAPSULES OF 50MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugdosagetext>TWO TABLETS OF AN UNKNOWN DOSE TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556285-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.259</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556286-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012086738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.005</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556287-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556288-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT PHYSICAL ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556289-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556290-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012164361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>^80 MG^, WEEKLY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556291-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556292-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556293-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012053719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugbatchnumb>0008-1222-01</drugbatchnumb>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 UNK, ONCE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>ISO I, ONCE A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556294-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>B10542730</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556295-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>900 MG/DAY</drugdosagetext>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556296-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PARAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V120539</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BURNING SENSATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556297-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, ALTERNATE DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556298-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012166179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>112 UG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556300-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556301-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugindication>MICTURITION DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556302-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SUL HYT</medicinalproduct>
        <drugauthorizationnumb>18565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556303-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012170100</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugbatchnumb>0923091</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1000 (UNITS NOT PROVIDED), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556304-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556305-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>150 MG, ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556306-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556307-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556308-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012151483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556309-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556310-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMATURE MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556311-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556312-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182503</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>25 UG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556313-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556314-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>A219601</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556315-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556316-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>F76543</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556317-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556318-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA ZYDIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556319-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120705214</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugdosagetext>1 PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556320-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556321-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>FOR 3 MONTHS</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>20083</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B-DEOXYCHOLATE</medicinalproduct>
        <drugdosagetext>FOR 4 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556322-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556324-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556325-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP034049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>736049</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556326-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>671</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556327-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556328-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP026607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugbatchnumb>905306</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>68 MG, 3YEARS</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556329-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1202USA02477</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>68 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111129</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>100 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111019</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>100 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>1 UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>1 UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANDEL</medicinalproduct>
        <drugdosagetext>1 UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANDEL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556330-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN010993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101012</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>400 MG IN THE MORNING, 200 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>THE DIVIDED DOSE FREQUENCY IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110204</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556333-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROHEPTADINE</medicinalproduct>
        <drugdosagetext>4 MG, AS NEEDED</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugbatchnumb>Y06943</drugbatchnumb>
        <drugdosagetext>1.6 MG, DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556334-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012177534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.365</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556335-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugauthorizationnumb>021234</drugauthorizationnumb>
        <drugindication>HIP SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugauthorizationnumb>021234</drugauthorizationnumb>
        <drugdosagetext>1.3 %, EVERY 12 HOURS</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556337-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556338-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugauthorizationnumb>018147</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556339-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012151658</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>C10015830</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556340-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183101</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556341-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012149427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugbatchnumb>Z00090</drugbatchnumb>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugbatchnumb>Z00679</drugbatchnumb>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OPTIC NERVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556342-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>172</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>ATRIOVENTRICULAR BLOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>125 UG, DAILY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 2X/DAY</drugdosagetext>
        <drugindication>ATRIOVENTRICULAR BLOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugindication>ATRIOVENTRICULAR BLOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>F60759</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>600 MG, EVERY 4 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugindication>ATRIOVENTRICULAR BLOCK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556343-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-FRI-1000037210</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMPHYLLIN RETARD</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TROMPHYLLIN RETARD</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556344-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-JNJFOC-20120711853</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>REPLACEMENT DOSES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>018533</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556345-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120714478</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556346-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120708082</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ON DAYS 1, 4, 8 AND 11</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1 (AND DAY 8 OF CYCLE 1)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugdosagetext>FROM DAY 20 TO 29</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>FROM DAY 1 TO 4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556347-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120708083</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugdosagetext>FROM DAY 20 TO 29.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ON DAYS 1, 4, 8 AND 11</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1 (AND DAY 8 OF CYCLE 1)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 TO 4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AS A CONTINUOUS INFUSION FROM DAY 1 TO 4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>AS A CONTINUOUS INFUSION FROM DAY 1 TO 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556348-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120708084</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAY 1 TO 4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>AS A CONTINUOUS INFUSION FROM DAY 1 TO 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AS A CONTINUOUS INFUSION FROM DAY 1 TO 4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ON DAYS 1, 4, 8 AND 11</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugdosagetext>FROM DAY 20 TO 29.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1 (AND DAY 8 OF CYCLE 1)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556349-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK, 1 ROD</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556350-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556351-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-11P-020-0886221-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 TB AM, 2 TB PM, ON MONDAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOXICAM</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>SOMETIMES SHE USED HALF TABLET A DAY</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>4 TABLETS EVERY MONDAY, ONCE</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556352-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE065647</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY OF PARTNER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556353-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US03258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0169</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0175</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556354-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012180920</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>20 MG / 12.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556355-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012182317</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556356-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012184187</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556357-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012183963</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ZINC PROTAMINE INJECTION</medicinalproduct>
        <drugdosagetext>80-100 IU/ML, ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556358-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP064652</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556359-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP062673</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNORING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPOKINESIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKINESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556360-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065371</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG, ONE EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, ONE EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON DEXTRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556361-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US011718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOBULINS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIRY CELL LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ICAPS PLUS</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>H2 BLOCKER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugindication>ANAEMIA HAEMOLYTIC AUTOIMMUNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF (25-50 MG)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>10 MEQ, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556362-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA28394</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556363-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065367</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.005</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556364-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US005585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugbatchnumb>F0028</drugbatchnumb>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120303</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIINFLAMMATORY/ANTIRHEUMATIC NON-STEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>URTICARIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>7.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2.5 MG, PRN</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556365-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US008475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556366-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556367-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT FORMULATION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>BLB0Z00</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556368-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>CBB4H00</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556369-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120703213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>500/7.5 MG DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS CHORIORETINITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>020325</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYCOBACTERIUM AVIUM COMPLEX INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugdosagetext>200/300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugauthorizationnumb>020325</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RIFABUTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556371-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712898</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556372-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712433</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10/325MG/TABLET EVERY 4 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>10/12.5MG/TABLET ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>2-3 PATCHES AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556373-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120712455</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAINDICATION TO VACCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INFLIXIMAB STOPPED AFTER THE PATIENT RECEIVED 6 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECOMBINANT HEPATITIS B SURFACE ANTIGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556374-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>40 MG PER 0.8 ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>REGURGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>VITAMIN D DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD IRON DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556375-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712815</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556376-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CR064811</companynumb>
    <primarysource>
      <reportercountry>COSTA RICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RESTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE TIMING UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>MATERNAL DOSE:</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE:</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556377-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US04180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugdosagetext>1 DRP, Q12H</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>LACRIMATION INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugbatchnumb>F0010</drugbatchnumb>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>BLOOD URIC ACID</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRULINA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORELLA VULGARIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>IRON DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556378-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012KR065535</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG/ DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556379-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556380-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>320 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556381-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011BR92979</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>0.5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>3 DF,  TABLETS A DAY FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>80 MG, 60 TO 80 MG FOR 23 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>2 DF, 12/400 2 CAPSULES EVERY 4 HOURS FOR 23 YEARS</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugdosagetext>ONCE EVERY 4 HOURS OR EVERY 6 HOURS, MANY YEARS</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556383-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU061839</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556384-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003490</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556385-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012EC036762</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556386-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA051662</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CALCIFICATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>150 MG, 1 PER DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.125 MG, QD (ALT DAYS)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE AQUEOUS</medicinalproduct>
        <drugdosagetext>1-2 PER DAY</drugdosagetext>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, 1 X DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 IU, 1 X DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG. 0.5 OR 1 AS REQUIRED</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, 1 PER DAY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>ANNUALLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE (PRISOLEC)</medicinalproduct>
        <drugdosagetext>20 MG, 1-2 PER DAY</drugdosagetext>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.112 MG, QD (ALT DAYS)</drugdosagetext>
        <drugindication>AUTOIMMUNE THYROIDITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556387-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556388-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU064506</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450 MG, NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556389-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP059583</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556390-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NL064414</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIPATCH</medicinalproduct>
        <drugauthorizationnumb>020870</drugauthorizationnumb>
        <drugdosagetext>1 DF, QW2</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>POSTMENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556391-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DZ065525</companynumb>
    <primarysource>
      <reportercountry>ALGERIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556392-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065648</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556393-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR064333</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG (1 AMPOULE OF 10ML), QMO</drugdosagetext>
        <drugindication>ACROMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556394-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065252</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGALDRATE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/ 100 ML, EACH YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELMAC</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556395-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004012</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556396-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556398-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011US56008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTROCYTOMA, LOW GRADE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, THREE TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, THREE TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THORAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, THREE TIMES A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>2.5 MG EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556399-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF(160 MG VAL/ 12.5 MG HCT) BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556400-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065722</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>20370</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556401-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012JP004335</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
        <drugtreatmentduration>164</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPETO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AIN457</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120131</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556402-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP031111</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111010</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9 MG/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111019</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556403-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENZYME LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE PERCENTAGE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>360 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556404-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US05062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MINERAL METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0140</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0140</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG (3 TABLETS), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG IN MORNING AND 2MG IN QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 DF, PRN DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXEDRINE</medicinalproduct>
        <drugdosagetext>UNK UKN, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE D3</medicinalproduct>
        <drugdosagetext>2000 U, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK UKN, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK UKN, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICA</medicinalproduct>
        <drugdosagetext>UNK UKN, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK UKN, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556405-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US016486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMATOUS LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAPULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071120</drugenddate>
        <drugtreatmentduration>1945</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>LUNG NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C AND E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEINASE INHIBITORS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRICAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNVISC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE +D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA                                  /USA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.125 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN W/PHENOBARBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>METASTASES TO SPINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>10 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>110 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>CALCIUM DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B12 ^RECIP^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556406-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065132</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT LOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE ASSOCIATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>1 DF (200/50/12.5 MG), DAILY</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>2 DF (200/50/12.5 MG), DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556407-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR044542</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556408-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US00483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PROSTHESIS USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE MALEATE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULVESTRANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556409-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065608</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHERGINE</medicinalproduct>
        <drugauthorizationnumb>006035</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>BLIGHTED OVUM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556410-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003161</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>(250 MG) 50 MG AT MORNING AND 200 MG AT NIGHT, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>79</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100 MG AT MORNING AND 50 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>75 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENETOROL</medicinalproduct>
        <drugdosagetext>300 MG, DAILY AT NIGNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556411-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065103</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN UNEXPLAINED DEATH IN EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556412-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEARNING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556413-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BE057077</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, UNK</drugdosagetext>
        <drugindication>HAEMOCHROMATOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556414-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US010612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556415-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugbatchnumb>F0010</drugbatchnumb>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556416-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065700</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/ 100 ML ONCE BY YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556417-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012LB065676</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDULAR</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASCOR</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1 DF, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556418-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065727</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100 ML/YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556419-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065381</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556420-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065697</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML , EACH YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556421-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP006817</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSA EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL EROSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>125 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCHONDRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYCHONDRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556422-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065728</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML/YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556423-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065376</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556424-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065715</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (160/25 MG), UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556425-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065805</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556426-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011BR76076</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugdosagetext>1 DF, Q8H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>3 DF, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>20 DF, TID</drugdosagetext>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORINE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACONDRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSILAX</medicinalproduct>
        <drugdosagetext>1 DF, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETNOVATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556427-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP057489</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>100 MG, IN TWO DOSES PER DAY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556428-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014838</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556429-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US000508</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO ABDOMINAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556430-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA76722</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE SYRUP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG ONCE A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugdosagetext>05 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556431-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012PT047002</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556432-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US00492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF ADRENAL GLAND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYCOPENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETASON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITA-E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, ONCE/SINGLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG,  DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556433-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP045501</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD AVERSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.5MG DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.5MG DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556434-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA049518</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556436-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2011SA059126</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAZITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCERIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXETHAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAZITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIAZULE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110823</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556437-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065729</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556438-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU064675</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556439-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065782</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, BID</drugdosagetext>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556440-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP002974</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110518</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>10 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIZE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110521</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556441-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP065068</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL FLUCTUATING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ANTIMICROBIAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556442-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US002347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugauthorizationnumb>020538</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556443-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065684</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556444-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065640</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>2 DF, PER DAY</drugdosagetext>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>52 IU, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (160/5 MG) PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUTRIN</medicinalproduct>
        <drugdosagetext>1 DF, PER DAY</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1 DF, PER DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556445-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA21027</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>30 MG, BIW</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556446-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP50217</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110502</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110518</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>625 MG, ON ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>8 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>10 DF, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>4 U, EVERY THREE WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110831</drugenddate>
        <drugtreatmentduration>350</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110403</drugenddate>
        <drugtreatmentduration>565</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100202</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>6 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100421</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>14 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>4 U, EVERY TWO WEEKS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTOL-XE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>15 U, EVERY 3 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110605</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>12 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>10 DF, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>15 U, EVERY 3 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110511</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
        <drugdosagetext>0.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556447-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA034898</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19921001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556448-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2011GB03696</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556449-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA034681</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG/ 24 HOURS (9MG/5 CM2/ 24 HRS)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556450-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA064956</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVO-LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556451-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA062296</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450 MG, QHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>1.5 MG,(1 MG AM, 0.5 MG AT LUNCH)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556452-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP062047</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMOSOME ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NILOTINIB</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556453-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP59737</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100620</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugdosagetext>300 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556454-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012HN065695</companynumb>
    <primarysource>
      <reportercountry>HONDURAS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556455-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065724</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556456-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA039556</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.4</patientweight>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 UKN, TID</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556457-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065686</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, ONCE A YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556458-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA029220</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556459-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012TR060267</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, ONCE EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556460-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556461-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GR065457</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPIRONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>22334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUFALONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T4</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugindication>DEMENTIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556462-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012TR065780</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG ONCE EVERY 28 DAYS</drugdosagetext>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556463-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556464-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US04455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.621</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH GLAND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTHESOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556465-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004249</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556466-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVEDO RETICULARIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION IN AN IMMUNOCOMPROMISED HOST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556467-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA62209</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK UKN, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>20 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556468-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CO065282</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, (INTERMITENT)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>25 MG, PER NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556469-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA064801</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556470-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US001480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10/325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>6.5 MG/H, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
        <drugtreatmentduration>659</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>3 G, DAILY</drugdosagetext>
        <drugindication>PLEURAL EFFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556471-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556472-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US02799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREAURICULAR CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROCHOLECYSTIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOMYOLIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ANKYLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PECTUS EXCAVATUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURADRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556473-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA064297</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556474-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012PH065781</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556475-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BG064931</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556476-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004253</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECAPEPTYL - SLOW RELEASE</medicinalproduct>
        <drugdosagetext>11.25 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556477-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US00500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASON ^COPHAR^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556478-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugauthorizationnumb>021485</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556479-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR065756</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF (160MG VALS/ 5MG AMLO), DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556480-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN047883</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLAST CRISIS IN MYELOGENOUS LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556481-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MY057406</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>453</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556482-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA008644</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556483-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA63599</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556484-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012EC065807</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE REPLACEMENT COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG / 100 ML STAT YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556485-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351211USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556486-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN065930</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556487-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA49994</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANGIODYSPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>1211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556488-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IQ065670</companynumb>
    <primarysource>
      <reportercountry>IRAQ</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG, PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556489-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR055743</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD (320 MG VALS AND 25 MG HYDRO)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556490-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BE065768</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556491-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA027850</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, ONCE A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556493-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN065776</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556494-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065812</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG/24 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556495-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065864</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556496-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA029210</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556497-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU028822</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556498-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012IE001075</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>500MG MANE + 100MG NOCTE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEILMED</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>325 MG, UNK (125 MG MANE AND 200 MG NOCTE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, MANE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>1000 MG, NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FYBOGEL ORANGE</medicinalproduct>
        <drugdosagetext>1 SACHET BD PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5 MG, NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KWELLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>550 MG (150 MG MANE, 50 MG AT 13:00 HRS AND 350 MG NOCTE))</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugdosagetext>1500 MG, DAILY (500 MG MANE AND 1000 MG NOCTE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>300 UG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QDS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>625 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556499-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR055790</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>320 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556500-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004234</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556501-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US10894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.11</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESORPTION BONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBOHYDRATE ANTIGEN 27.29 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLEEN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SUPPLEMENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANTINEOPLASTIC AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556502-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065752</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>1 DF,</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>898</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>16 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>898</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>3820</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 G DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>1264</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556503-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN065899</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556504-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR055787</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL WEDGING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>160/5 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556505-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AT065753</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>500 MG, (5-0-5)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111020</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugbatchnumb>S020</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>H0126B05</drugbatchnumb>
        <drugdosagetext>1380 MG, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>H0107B01</drugbatchnumb>
        <drugdosagetext>1380 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556506-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU065828</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556507-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR054405</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODOPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>0.5 DF, UNK (VALS 320 MG AND AMLO 10 MG),</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODOPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK (VALS 320 AND AMLO 10 MG)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODOPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK (VALS 160 MG AND AMLO 5 MG) IN MORNING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556508-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN065735</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556509-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008CA05816</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN-LIKE GROWTH FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GROWTH HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556510-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP029137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>863761</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556511-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-022082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>Q 4-6 HRS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>QHS ( EVERY NIGHT AT BED TIME)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>2000 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>0.5-1 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>PRN (AS NEEDED)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556512-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DK049867</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE DISSEMINATED ENCEPHALOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556514-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2012SA028494</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAZITAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556515-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556516-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0960845-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugdosagetext>4 MONTHS DEPOT</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556517-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-12P-020-0951770-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL INDUCTION OF COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>WEEK 2, 80 MG</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>WEEK 0, 160 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556518-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SANOFI-AVENTIS-2012SA019766</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556528-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-083601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LO/OVRAL-28</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556529-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201035756NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.238</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPYRINE W/BENZOCAINE</medicinalproduct>
        <drugadministrationroute>001</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556530-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-075157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556531-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-050148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>144</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556532-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-014783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090811</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556533-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-015012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
        <drugtreatmentduration>265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080324</drugenddate>
        <drugtreatmentduration>265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556534-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BAYER-2012-048359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugdosagetext>3 DF, TID</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH MIXTURE A</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>294</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugdosagetext>3 DF, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEN U.S.</medicinalproduct>
        <drugdosagetext>9 G, TID</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEN U.S.</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556535-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201013985NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>151.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556536-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA012562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556537-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556538-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP034053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556539-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP034755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>20903</drugauthorizationnumb>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>150MCG, WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MCG, WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556540-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>BA8209A</drugbatchnumb>
        <drugdosagetext>0.3 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556541-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EST</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556542-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00F5Z</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556543-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-017449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40 MG / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556544-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-036928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.621</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DIET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORGARD</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>ANAEMIA OF PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556545-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-SANOFI-AVENTIS-2012SA052375</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugdosagetext>DOSE:10 UNIT(S)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DEVICE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556546-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-SANOFI-AVENTIS-2012SA037317</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL HCL + HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>QUINAPRIL 20 MG + HYDROCHLOROTHIAZIDE 12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110904</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556547-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-SANOFI-AVENTIS-2012SA047738</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRONEDARONE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556548-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-AVENTIS-2012SA042436</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAZITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556549-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011072</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556550-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556551-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-ESPCT2012013789</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIXTARD HUMAN 70/30</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>3 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDAPTAN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CAROTID BRUIT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRADIN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556552-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTRANS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>10 MCG/HR, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556553-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-SANOFI-AVENTIS-2012SA052121</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRONEDARONE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556554-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2011SA065119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPROPYL ALCOHOL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556555-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MILLENNIUM PHARMACEUTICALS, INC.-2011-03283</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COXSACKIE VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>9 MG/M2, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.07 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556556-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MPIJNJ-2011-06600</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111115</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIC                               /00587301/</medicinalproduct>
        <drugdosagetext>400 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111221</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDIN</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111221</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111221</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556557-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MPIJNJ-2012-05282</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPIGLOTTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER AIRWAY OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556558-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MILLENNIUM PHARMACEUTICALS, INC.-2011-02429</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugdosagetext>9 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110520</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-TRIMAZOLE</medicinalproduct>
        <drugdosagetext>960 MG, BID</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110604</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110528</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556559-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MPIJNJ-2011-00589</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>96 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDO K                            /00031402/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1440 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>80 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556560-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MILLENNIUM PHARMACEUTICALS, INC.-2012-00957</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.8 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556561-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MILLENNIUM PHARMACEUTICALS, INC.-2012-02593</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081010</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>105 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081010</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080912</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081010</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>3.3 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>1600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556565-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556566-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351194USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556567-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugbatchnumb>21535B</drugbatchnumb>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>7.5 ML, ONCE</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556568-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMPRIN TAB</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES</medicinalproduct>
        <drugdosagetext>2 PUFF(S), EVERY 6 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG - 325 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugdosagetext>500 MG, EVERY 12 HOURS FOR 7 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556569-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-071526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 ?G, 1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111212</drugenddate>
        <drugtreatmentduration>1196</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556570-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>DYSFUNCTIONAL UTERINE BLEEDING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>0.112 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556572-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-040382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>METRORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556573-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-065362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556574-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-021126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556575-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-021291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090102</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>5MG/500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556576-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-046802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556577-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-012043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556578-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2010-002143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>116.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBERCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556579-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2012SA051641</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JEVTANA KIT</medicinalproduct>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugdosagetext>START DATE: APPROX TWO WEEKS AGO</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556580-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350970USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556581-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959596-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVER SULFADIAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMYCIN SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTICORT ENERIC COATED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556590-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE32254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FORMATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLAIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>5/500 MG TAKEN WHEN NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>ONE A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>EMOTIONAL DISTRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG TAKEN WHEN NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>5 MG/500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>TQD FOR (30) NR</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>ONCE A MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>75 MG 1/2 TAB DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>EMOTIONAL DISTRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556592-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>40 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556593-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SP-2012-07245</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556594-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>60 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556598-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN005833</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMYLASAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80MCG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556599-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2011SA075027</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B5027</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:15MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>H76543</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>H76543</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>H76542</drugbatchnumb>
        <drugdosagetext>DOSE: 6MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>H76542</drugbatchnumb>
        <drugdosagetext>DOSE: 6MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>B5027</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:15MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556600-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPRELSA</medicinalproduct>
        <drugauthorizationnumb>022405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556601-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16793580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>1DF:2-3 PUFFS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY CYTOKINE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>1DF:1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556602-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2012SA005133</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugdosagetext>DOSE: 60MG/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL: 6MG/KGFORM: VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>FORM: VIALSDOSE LEVEL: 5 AUC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>DOSE REDUCED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE REDUCED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>DOSE: TDD MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556603-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BRISTOL-MYERS SQUIBB COMPANY-16802985</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>INTERRUOTED:11MAY12 RESUMED:21MAY12</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556604-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16802365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>131</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>1 F= 1 CAN. ROUTE: PEG TUBE. 6-7 TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FLUORIDE</medicinalproduct>
        <drugdosagetext>DENTAL GEL 1.1% DT GEL. FOR 15-20MINS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>714692</drugbatchnumb>
        <drugdosagetext>INITIAL 978MG ON 18JUN12, THEN 610MG 25JUN2, 2JUL12, 9JUL12, 16JUL12. 250MG/M2 ONE/WEEK OVER 60MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PHARYNGEAL CANCER STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>1 DF= 1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>CAPS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>0.5% EX</drugdosagetext>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TABS. EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40MG. AT BEDTIME. 1 DF= 1 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FATTY ACID</medicinalproduct>
        <drugdosagetext>CAPS. EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>FORM: 15MG TABS. 1 DF= 0.5 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>FORM: 2.5MG TABS . 1 DF= 1 TABS. EVERY MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>EVERY 6 HRS. TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>0.5% EX</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>TABS. EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS</medicinalproduct>
        <drugdosagetext>1 DF= 1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>0.12% MT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>TABS. EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>THEN 1 TABS DAYS 2-14</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>FORM: 320-12.5MG. EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETACAROTENE</medicinalproduct>
        <drugdosagetext>CAPS. EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556605-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>15 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556606-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugbatchnumb>A81294M</drugbatchnumb>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556607-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001355</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugbatchnumb>A81294Q</drugbatchnumb>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556608-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556609-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16262297</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>18OCT11 REINDUCTION 200MG ON 13APR12-15JUN12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS + IRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556610-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556611-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-BRISTOL-MYERS SQUIBB COMPANY-16763807</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YERVOY</medicinalproduct>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556616-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16448656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>132</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1 DF : 1000 U</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugdosagetext>COURSE NUMBER: 1.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>1 DF : 2TABS</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>RECENT DOSE: 15FEB12, 71 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556617-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BRISTOL-MYERS SQUIBB COMPANY-16811143</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556618-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-FF-00983FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556619-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16361BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556620-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16566BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556621-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AU-01291AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>10/80</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556623-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-ROXANE LABORATORIES, INC.-2012-RO-01586RO</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALPHA 2A</medicinalproduct>
        <drugindication>HEPATITIS CHOLESTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>74069</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>HEPATITIS CHOLESTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugindication>LIVER FUNCTION TEST ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556624-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16221525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>LAST ADMINISTERED DT:17OCT2011,10MG/KG OVER 90MIN,Q3 WEEKS*4DOSES,Q12 ON WEEKS 24,36,48+60.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556625-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16741811</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER</medicinalproduct>
        <drugdosagetext>0.05%</drugdosagetext>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUNOL</medicinalproduct>
        <drugdosagetext>GARGLE 4%</drugdosagetext>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugindication>BLOOD SODIUM ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>78485</drugbatchnumb>
        <drugdosagetext>FORM: 5MG/ML.CYCLE 6 DAY22</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>ON DAY 8 OF EACH CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TS-1</medicinalproduct>
        <drugdosagetext>CAPS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>CAPSULE</drugdosagetext>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugdosagetext>0.3%</drugdosagetext>
        <drugindication>DRY SKIN PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOMEX</medicinalproduct>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556626-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-16778797</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 28JUN12 3 MG/KG OR 10 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556627-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16793853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRONCHODUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugbatchnumb>01459901</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>00661201</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugbatchnumb>00027401</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>00032601</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556640-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16813586</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>NO. OF COURSES:3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 DF: 1 TABLET</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>EVERY 4 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 2</medicinalproduct>
        <drugdosagetext>1 DF: 1-2 TABLETS, EVERY 6 HRS.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556641-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16788226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugauthorizationnumb>012041</drugauthorizationnumb>
        <drugdosagetext>KENALOG INJECTION  LATEST INJ: 05JAN11</drugdosagetext>
        <drugindication>TENOSYNOVITIS STENOSANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556642-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556643-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16556763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YERVOY</medicinalproduct>
        <drugbatchnumb>917376</drugbatchnumb>
        <drugdosagetext>3MG/KG-EVERY 21DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556644-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351191USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556645-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-16490120</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTUDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556646-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16825010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556647-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
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    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556648-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556649-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556650-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-064931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556651-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-017404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINI-PILL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050401</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556652-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040917</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556653-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556654-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556656-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
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        <drugdosagetext>UNK</drugdosagetext>
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        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556657-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-026995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-16461915</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAIL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>REINTRODUCED ON 12-MAR-2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>REINTRODUCED ON 12-MAR-2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>REINTRODUCED ON 12-MAR-2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556660-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-023908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.655</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556662-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-012255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>124.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOLOGICAL TRAUMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556663-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA045038</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>MAINTENANCE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugdosagetext>STARTING DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>89</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIDAPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROLOGICALS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556668-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-12072433</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 OR 25 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110512</drugenddate>
        <drugtreatmentduration>551</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556680-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP035660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugbatchnumb>905306-116012</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556681-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP030122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556682-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP049968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110929</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556683-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556684-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>050740</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ZYGOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556685-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ASTELLAS-2012EU005236</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>200 UNK, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE MALEATE</medicinalproduct>
        <drugdosagetext>1 DF, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556686-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTELLAS-2012US006580</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTELLAS-2012US006534</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556688-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTELLAS-2012US006535</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556689-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP006874</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>150 MG/M2, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>40 MG/KG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATG                                /00575401/</medicinalproduct>
        <drugdosagetext>5 MG/KG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556690-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012US006554</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556691-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120621</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556692-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP006577</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPES VIRUS 6 SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050709</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSCAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HUMAN HERPES VIRUS 6 SEROLOGY POSITIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556693-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP003270</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>4.5 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110726</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111114</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>0.5 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110530</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugdosagetext>3000 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110611</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110628</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110628</drugenddate>
        <drugtreatmentduration>380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>3600 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110604</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110830</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556694-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012US006266</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556695-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-2012-054186</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 800 MG</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 600 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090915</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>20 (?) 3/DIE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORUDIS</medicinalproduct>
        <drugdosagetext>3 DIE</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 600 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugdosagetext>DAILY DOSE 4 MG (Q 4 WEEKS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
        <drugtreatmentduration>425</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 600 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090904</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 16 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556696-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556698-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556699-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCAMINE</medicinalproduct>
        <drugbatchnumb>021640</drugbatchnumb>
        <drugauthorizationnumb>021506</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556700-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP005701</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>4 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556701-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZD6244 HYDROGEN SULFATE</medicinalproduct>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSTRUCTIVE UROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556704-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP003290</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110912</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO                               /00465701/</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>50709</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111004</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111119</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>70 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110829</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSINE                           /00784201/</medicinalproduct>
        <drugdosagetext>260 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111026</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugdosagetext>45 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110829</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1290 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110829</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556705-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NOCTURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556706-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006944</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556708-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTELLAS-2012EU005258</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>250 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>30 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051030</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>125 UG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>6 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006947</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556710-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006943</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556711-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006885</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556712-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMEVIVE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556713-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006942</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL AND PANCREAS TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556714-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556715-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006945</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556716-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTELLAS-2011US003227</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugdosagetext>2.25 G, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVALGINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556717-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[NO SUSPECT PRODUCT]</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556718-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556719-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP006909</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE IN SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATG                                /00575401/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556720-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556721-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006946</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556722-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP002122</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYRBETRIQ</medicinalproduct>
        <drugdosagetext>50 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111221</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111206</drugenddate>
        <drugtreatmentduration>1916</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111211</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111218</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556723-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX                           /01202601/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556724-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP002456</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN                           /00036201/</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120303</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZALIN                           /00036201/</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUNGUARD</medicinalproduct>
        <drugauthorizationnumb>21506</drugauthorizationnumb>
        <drugdosagetext>75 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>FUNGAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120324</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDACTONE</medicinalproduct>
        <drugdosagetext>200 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PLEURAL EFFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120324</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPAREN 2</medicinalproduct>
        <drugdosagetext>1.5 L, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPAREN 2</medicinalproduct>
        <drugdosagetext>1 L, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120324</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLDACTONE</medicinalproduct>
        <drugindication>ASCITES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN ELECTROLYTES IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>500 ML, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MALNUTRITION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLARICID                           /00984601/</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120302</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugdosagetext>1.8 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120302</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN                           /00038601/</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120303</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN                           /00038601/</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PICILLIBACTA</medicinalproduct>
        <drugdosagetext>3 G, BID</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugdosagetext>1 G, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOPAREN 1</medicinalproduct>
        <drugdosagetext>1.5 L, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556725-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556726-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-2012182735</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>10151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556727-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012183645</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556728-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-PFIZER INC-2012183512</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556729-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-PFIZER INC-2012182705</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRACAINE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>17106</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TROPICAMIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556730-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-PFIZER INC-2012183444</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556731-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012183743</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>20151</drugauthorizationnumb>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556732-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012174801</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLEXES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEKOVIT CA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>125 UG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM PICOSULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556733-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0933775-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDIATOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18723</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE/VILDAGLIPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556734-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0952645-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556735-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0949414-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT HYPEREXTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022224</drugauthorizationnumb>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugindication>INCREASED APPETITE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugdosagetext>EVERY 4-6 HOURS</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>GOUTY ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugdosagetext>1 PACKET 2-4 TIMES DAILY</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556745-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-2012SP033787</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORNEAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>80 ?G, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556746-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP031284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>3 YEAR IMPLANT</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556747-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1203USA01997</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>64 MG, QM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>64 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.4 MG/M2, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>160 MG, QM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.4 MG/M2, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>160 MG, QM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556748-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-TEVA-349941ISR</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070943</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOXICITY TO VARIOUS AGENTS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556749-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-349947ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2.5MG GLIBENCLAMIDE/400MG METFORMIN 3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NADROPARIN CALCIUM</medicinalproduct>
        <drugdosagetext>3800 IU (INTERNATIONAL UNIT);</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>ENALAPRIL 20MG/HYDROCHLOROTHIAZIDE 12.5MG ONCE/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>76361</drugauthorizationnumb>
        <drugdosagetext>500 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugdosagetext>35 MICROG/HOUR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556750-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556751-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAYER-2012-075755</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556752-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556753-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556754-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
        <drugindication>BLOOD PRESSURE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556755-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER NON-FUNCTIONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556756-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-015041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556757-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAYER-2012-055800</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111106</drugenddate>
        <drugtreatmentduration>251</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556758-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556759-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-015075</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.698</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060118</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061010</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080317</drugenddate>
        <drugtreatmentduration>525</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556760-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-051522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556761-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-084514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556762-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556763-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE76007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN LA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL NORETHINDRONE</medicinalproduct>
        <drugdosagetext>1.0 TO 0.5 MG ONE PO QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 WITH D 600MG-200 U TABLET ONE PO BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>750 MG TABLET 1 PO TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 TO HALF PO BID/PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN SODIUM</medicinalproduct>
        <drugdosagetext>550 MG ONE PO BID PRN WITH FOOD 7 TO 10 D AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020305</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>500 TO 10 MG, ONE PO Q8H PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>10/500 MG ONE PO TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTAL/APAP/CAFF PLUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556764-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556766-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1107USA03286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN C DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOGENESIS IMPERFECTA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060210</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070504</drugenddate>
        <drugtreatmentduration>390</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
        <drugtreatmentduration>640</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556772-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556773-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-12072263</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugdosagetext>60 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556774-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-ROXANE LABORATORIES, INC.-2012-RO-01587RO</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICES OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugindication>HEPATITIS CHOLESTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>HEPATITIS CHOLESTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>74069</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugindication>LIVER FUNCTION TEST ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556775-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16482BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556776-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AU-01307AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556777-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-12072434</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556778-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-NL-00302NL</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENPROCOUMON</medicinalproduct>
        <drugdosagetext>DOSAGE ACCORDING TO SCHEDULE INTENSIVE CARE FOR THROMBOTIC PAT.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556779-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-356857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556780-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-NOVOPROD-351708</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>196</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556781-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-356507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021536</drugauthorizationnumb>
        <drugdosagetext>57 U, QD, AT NIGHT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>35 U, TID, BEFORE EACH MEAL</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556782-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NOVOPROD-317631</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN-LOSING GASTROENTEROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.12 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>0.45-0.8 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>1545</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN K</medicinalproduct>
        <drugdosagetext>1.6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRECOCIOUS PUBERTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101031</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>2.2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556783-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-356645</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>N/A</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>FOR 15 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556784-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-356773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>39.456</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN FLEXPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NOONAN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556785-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-353910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>148</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HCL</medicinalproduct>
        <drugdosagetext>10/40</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556786-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-356785</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UK</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVERSYL                           /00790702/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556787-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-356690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugbatchnumb>BP50554</drugbatchnumb>
        <drugauthorizationnumb>021172</drugauthorizationnumb>
        <drugdosagetext>52 UNITS, TWICE  A DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556788-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CTI_01473_2012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLAIR</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYFLO CR</medicinalproduct>
        <drugauthorizationnumb>022052</drugauthorizationnumb>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556802-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19841024</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-84110043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556803-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556804-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA01357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110517</drugenddate>
        <drugtreatmentduration>3789</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556805-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12072252</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556806-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-11093544</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111014</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110928</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111016</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556807-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556808-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-11P-066-0732548-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021606</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556809-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EK1</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-066687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.667</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556812-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00BUG</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556813-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00ER1</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556814-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556815-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-062575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.878</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556816-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYPHILIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE COMPONENT ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GONORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556817-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556818-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2012-073658</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>187.5 ?G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIALEBEX</medicinalproduct>
        <drugbatchnumb>12L04199</drugbatchnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>8 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120602</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556819-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2011-018515</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>600MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110224</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110929</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugdosagetext>DAILY DOSE 12.45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERATINAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALINAMIN F [FURSULTIAMINE]</medicinalproduct>
        <drugdosagetext>DAILY DOSE 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110512</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>DAILY DOSE 600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110720</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPUTUM RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556820-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350718USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>88497</drugauthorizationnumb>
        <drugdosagetext>500 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556821-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556822-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556823-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556824-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-65873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP014P0101/IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556825-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556826-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556827-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA00ABP</drugbatchnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556828-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556829-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556830-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA009PZ</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556831-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556832-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556833-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-68762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556834-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP038P0104</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA00ABP</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556836-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556837-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2011-56207</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIEMANN-PICK DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111030</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110909</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110523</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARLODEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>21348</drugauthorizationnumb>
        <drugdosagetext>150 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NIEMANN-PICK DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110608</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111222</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIO-THREE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110414</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>450 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110419</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110425</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110512</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120303</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110406</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111013</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIGLUSTAT</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>150 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANTRIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556842-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE53230</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>706</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOPROLIFERATIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556844-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VERTEX PHARMACEUTICALS INC.-000000000000001275</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556845-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-VERTEX PHARMACEUTICALS INC.-AE-2012-002626</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VX-950</medicinalproduct>
        <drugauthorizationnumb>71832</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556846-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-VERTEX PHARMACEUTICALS INC.-000000000000001249</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugbatchnumb>365181</drugbatchnumb>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: INJECTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556847-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VERTEX PHARMACEUTICALS INC.-000000000000000292</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMIDE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: AMPOULES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO (TELAPREVIR)</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556851-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007789</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOMEX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONA</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556852-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007250</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556853-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008227</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556859-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556860-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-008400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>A74481Z</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugbatchnumb>244039</drugbatchnumb>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B1003B17</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-2012-074432</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE/DIENOGEST</medicinalproduct>
        <drugbatchnumb>WEF69S</drugbatchnumb>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE/DIENOGEST</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-056429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-056075</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI FACTOR VIII ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>10230 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>10230 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2X64</drugbatchnumb>
        <drugdosagetext>2600 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>14322 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2X64</drugbatchnumb>
        <drugdosagetext>2600 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2JT1</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>14322 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>10230 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>ON DEMAND USE</drugdosagetext>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>CONTINUOUS INFUSION</drugdosagetext>
        <drugindication>HAEMOPHILIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>PROPHYLAXIS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N1T21</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2R21</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>10230 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N25</drugbatchnumb>
        <drugdosagetext>7161 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>021473</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSEUDOMONAS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>021473</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-BAYER-2012-052665</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-056034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI FACTOR VIII ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>CONTINUOUS INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>CONTINUOUS INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2HH2,27N2N23</drugbatchnumb>
        <drugdosagetext>1710U, 2046U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N23,27N2HH2</drugbatchnumb>
        <drugdosagetext>3069U, 576 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2X23</drugbatchnumb>
        <drugdosagetext>2130 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XW1,27N2WG1</drugbatchnumb>
        <drugdosagetext>6144U, 13021U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N32G2</drugbatchnumb>
        <drugdosagetext>18612 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N32G2,27N31G1</drugbatchnumb>
        <drugdosagetext>18612U, 264 U, 4136U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>PROPHYLAXIS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XW1</drugbatchnumb>
        <drugdosagetext>PROPHYLAXIS FOR ONE MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>CONTINUOUS INFUSION</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2PG2,27N2XK2</drugbatchnumb>
        <drugdosagetext>528 U, 6848 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XW1,27N2X64</drugbatchnumb>
        <drugdosagetext>1024U, 520U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N32G2,27N31H3</drugbatchnumb>
        <drugdosagetext>18612U 4136U, 8576U,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N31G1</drugbatchnumb>
        <drugdosagetext>264 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N32G2,27N3082</drugbatchnumb>
        <drugdosagetext>9306U,8272U 1039U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>CONTINUOUS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2N21,27N2HH2</drugbatchnumb>
        <drugdosagetext>5115U, 6840U,  3069U, 570U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XK2,27N2X23,</drugbatchnumb>
        <drugdosagetext>4084 U,10636 U,8520U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XK2,27N2XW1</drugbatchnumb>
        <drugdosagetext>2042U,1024U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XW1,27N2WG1</drugbatchnumb>
        <drugdosagetext>7168 U,14553U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2RT4</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N32G2</drugbatchnumb>
        <drugdosagetext>19646U , 9306U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2X23,27N2XK2</drugbatchnumb>
        <drugdosagetext>10650U,10210U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XW1</drugbatchnumb>
        <drugdosagetext>6144 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2PG2</drugbatchnumb>
        <drugdosagetext>204 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N32G2</drugbatchnumb>
        <drugdosagetext>25850 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2HH2,27N2N21</drugbatchnumb>
        <drugdosagetext>1710U, 2046</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2T51,27N2XK2,</drugbatchnumb>
        <drugdosagetext>4096 U, 7147 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2XW1,27N2PG2</drugbatchnumb>
        <drugdosagetext>8192U, 528U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2TJ2,27N2X23</drugbatchnumb>
        <drugdosagetext>1978 U,1065U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2WG1</drugbatchnumb>
        <drugdosagetext>PROPHYLAXIS FOR ONE MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2WG1</drugbatchnumb>
        <drugdosagetext>2116 U, 2316 U,8520 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2WG1</drugbatchnumb>
        <drugdosagetext>12696 U</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-2012-073852</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ECTOPIC PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE/DIENOGEST</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1063670</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN (CANADA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556875-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1056268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 5885 (HCV NS5A INHIBITOR)</medicinalproduct>
        <drugdosagetext>DF</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 9451 (NS3 PROTEASE INHIBITOR)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TEGOBUVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 5885 (HCV NS5A INHIBITOR)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 9451 (NS3 PROTEASE INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556876-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556877-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012051393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071229</drugenddate>
        <drugtreatmentduration>97</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012161463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugauthorizationnumb>17783</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>20 IU, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556881-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>4 MG, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V120069</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG,DAILY</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V120069</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556882-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, (FREQUENCY UNSPECIFIED)</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556883-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556884-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556885-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012055216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556886-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012162648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugauthorizationnumb>20329</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556887-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012173192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556888-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556889-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556890-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556891-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556892-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012171403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>TREMOR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556893-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556894-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-ROXANE LABORATORIES, INC.-2012-RO-01588RO</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugauthorizationnumb>74069</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELTACORTIL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556895-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556896-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008794</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556898-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008485</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556899-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PK-ROXANE LABORATORIES, INC.-2012-RO-01589RO</companynumb>
    <primarysource>
      <reportercountry>PAKISTAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAFT DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>74069</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DELTACORTRIL</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556900-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012118919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.481</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG DAILY X28 DAYS Q 42 DAYS</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE EXTENDED RELEASE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556901-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556902-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012160616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugauthorizationnumb>011909</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556903-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012170940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556904-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556905-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556906-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.574</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556907-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-1074096</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugbatchnumb>1101230</drugbatchnumb>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO THE EVENT: 'SECOND PRIMARY MELANOMA' ON 28/MAY/2012. LAST DOSE PRIOR TO ANEMIA ON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugbatchnumb>1101230</drugbatchnumb>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO THE EVENT: 'SECOND PRIMARY MELANOMA' ON 28/MAY/2012. LAST DOSE PRIOR TO ANEMIA ON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556908-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16399YA</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVASCULAR MEDICATIONS</medicinalproduct>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556909-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1075089</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugdosagetext>3 AMPOULES IN TOTAL</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>VISUAL IMPAIRMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556910-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA003356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556911-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16445BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556912-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16551BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556913-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1074755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556914-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011000771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.887</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC                           /00022001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugdosagetext>100 UNK, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>20000 IU, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556915-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1015235</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LENS DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MACULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556916-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-1081082</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556917-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-ROCHE-1051754</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>B1579</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>B1579</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D0A152</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556918-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-1070895</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556919-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100211</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-1080964</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556920-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1034486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556921-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SENSORIMOTOR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>ON DAY 1AS INTRAVENOUS PUSH AND REPEATED ON DAY 8 OF EACH 21 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>ON DAY 1 AS INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>DAY 1-5, CAPPED AT 1.5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAY 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAY 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>ON DAY 1 EVERY 21 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAY 1-5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>ADMINISTERED OVER 3 TO 5 MINUTES; ON DAY 1 EVERY 21 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556922-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120715105</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556923-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120407788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>57894-030-01</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>57894-030-01</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556924-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120313652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRISO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID UNSPECIFIED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556925-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712409</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556926-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556927-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120712885</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556928-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1068288</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B60181B011,B60331</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B60181B011,B60331</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556929-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1082451</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DIALYSIS DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>NON DIALYSIS DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556930-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1075081</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGAMOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556931-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1011760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>73620</drugauthorizationnumb>
        <drugdosagetext>TOTAL DOSE IN MOST RECENT CYCLE: 49.920 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>073620</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556932-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ID-BAYER-2012-073634</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, TOTAL DAILY DOSAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556933-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEYAZ</medicinalproduct>
        <drugauthorizationnumb>022532</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556934-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87.982</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEYAZ</medicinalproduct>
        <drugauthorizationnumb>022532</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556935-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-074118</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VENOUS GAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 400 MG</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 600 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556936-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1076363</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>VISUAL IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556938-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1028735</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078C,S0077A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078C,S0077A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0078C,S0077A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556939-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, UNK</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
        <drugtreatmentduration>273</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556940-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>13838G</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>150 ML, ONCE (4 ML/S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>21908D</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556941-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075101</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556942-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00B6X</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556943-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-048735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.644</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00DT1</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556944-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TUOOE3A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556945-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-048723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE IN PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU0075A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111227</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556946-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1075640</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>MONTHLY DOSE 432 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090212</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100119</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugbatchnumb>00837601</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTELOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556947-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21660-12033560</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>021660</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556948-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1024381</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN (FRANCE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFERON-A</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556949-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-12P-217-0960816-00</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556950-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ABBOTT-12P-007-0962479-00</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556951-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20111201665</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>INTERVAL OF DOSING WAS SHORTENED FROM EVERY 6 WKS TO EVERY 4 WKS TO EXPLAIN THE ^ DOSE INCREASE^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERAL NUTRITION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556952-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120310693</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556953-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120714558</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556954-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556955-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120715356</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556956-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20120713783</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2ND INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556957-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120708728</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRA-ABDOMINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556958-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOPEDIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556959-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120715171</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556960-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120516289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556961-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120610605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556962-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-JNJFOC-20120712526</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556963-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANGIOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556965-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-AMGEN-FINSP2012032052</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>80 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556966-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351325USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556967-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008499</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556968-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556969-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120517615</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLGOUT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556971-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120402</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP048229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556972-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-009507513-1207CZE012516</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>82 MG/250 ML SALINE SOULTION/30MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>2000 MG/100ML SALINE SOLUTION/15MIN AFTER 6 HOURS AFTER THE END OF CHEMOTHERAPY ADMINSTRATION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>2000 MG/100ML SALINE SOLUTION/15MIN AFTER 12 HOURS AFTER THE END OF CHEMOTHERAPY ADMINSTRATION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugdosagetext>0.6 ML, AT 7 AM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXONA INJECTION</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>0.5 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
        <drugdosagetext>0.8 ML, AT 7 PM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugdosagetext>125 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>0-1-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>1200 MG/100ML SALINE SOLUTION/15MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>8230 MG DIVIDED 3X1000 ML FR (EACH INFUSION FOR 8 HOURS, IN TOTAL 24 HOURS) +MESNA 2000MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>SARCOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugdosagetext>80 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugdosagetext>80 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556973-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>018558</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556974-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU008A2</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556975-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-032699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON + VITAMIN C</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556976-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201030719NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>50 MC, 2 SPRAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556977-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008782</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOCHOLEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556978-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-ESPSP2012042542</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RONAME</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RONAME</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLEMIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUTRILNEO</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>767 MG, QWK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>236 MUG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
        <drugtreatmentduration>163</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>16 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>650 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556979-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120712536</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICNU</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556980-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.17</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>1200141P1;1202176P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>TREATED WITH 100 UG/HR AND 50 UG/HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556981-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN;1112792P1</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN;1112792P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556982-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120611113</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B DNA ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BILTRICIDE</medicinalproduct>
        <drugdosagetext>TREATMENT STOPPED AFTER 3 COURSES ON 28-APR-2012, 02-MAY-2012 AND 12-MAY-2012</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PARASITIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556983-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556984-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556985-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20120714851</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugdosagetext>200 MG/ 245 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556986-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RUPTURED CEREBRAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORTHO-NOVUM</medicinalproduct>
        <drugauthorizationnumb>018985</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556987-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-12071185</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12060690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI FOR HER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM/MILLILITERS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>100000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 UNIT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL AC</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACT</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>5 PERCENT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>400 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556991-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ASTRAZENECA-2012SE51642</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556992-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1089157</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556993-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1084502</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>MOST RECENT DOSE RECEIVED 06/JUN/2012, LAST DOSE OF DRUG RECEIVED 269 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>MOST RECENT DOSE RECEIVED 06/JUN/2012, LAST DOSE OF DRUG RECEIVED 460 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>918460</drugbatchnumb>
        <drugdosagetext>MOST RECENT DOSE RECEIVED 06/JUN/2012, LAST DOSE OF DRUG RECEIVED 1125 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556994-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-1084903</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556995-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1084283</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugbatchnumb>S0052A</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556996-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-341413USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>074949</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556997-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120713951</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556998-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120703473</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORIPENEM MONOHYDRATE</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugdosagetext>0.25 G THREE TIMES DAILY TOTALLING TO 0.75 GRAMS/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA ASPIRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8556999-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120707058</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557000-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120515712</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557001-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120612433</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE PSYCHOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>EVERY NIGHT AT BED TIME X EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugdosagetext>4/52</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugdosagetext>INITIATED AN DAY-8, AFTER INITIATION DOSE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>EVERY NIGHT X ONCE EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>EVERY DAY BEFORE NOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557002-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA-BLOCKER (NAME UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557003-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557004-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557005-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557006-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>ONE IN NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1111530P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557007-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120606707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT PACKAGING ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugbatchnumb>1111528P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557008-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120611857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugindication>WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557009-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120403071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>APPROXIMATE TOTAL OF 50 INFUSIONS ADMINSTERED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557010-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-1092816</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>500 MG 2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>150 MG 3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557011-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557012-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009043</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABOAL SR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557013-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0962020-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018723</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIPSYCHOTICS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557014-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557015-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1083581</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557016-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1087888</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLIXIMAB</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557017-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1083969</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugdosagetext>3 AMPOULES</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MACULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557020-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1088118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY LIGHT REFLEX TESTS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugindication>ARTHRITIS INFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>ARTHRITIS INFECTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557021-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1088308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR ISCHAEMIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>MOST RECENT DOSE PRIOR TO SAE ON 06/JUL/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557022-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1087773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>B131748</drugbatchnumb>
        <drugdosagetext>DOSE: 180 UG/WEEK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10/325 ONE TABLET 4 TO 6 HOURS AS NEEDED FOR PAIN.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugbatchnumb>B131742</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugbatchnumb>B131745</drugbatchnumb>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110602</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugbatchnumb>B131745</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557023-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351187USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557024-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1088281</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>29.6 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557025-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>RADIOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557026-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012136295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557027-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugbatchnumb>0261D3A</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugbatchnumb>0261D3A</drugbatchnumb>
        <drugauthorizationnumb>021812</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED DOSE (A LITTLE BIT)</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HAIR GROWTH ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557028-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120703830</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557029-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120713053</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIINFLAMMATORY DRUGS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557030-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERGROWTH BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCREAZE</medicinalproduct>
        <drugauthorizationnumb>022523</drugauthorizationnumb>
        <drugdosagetext>16000 UNITS LIPASE/WITH MEALS AND SNACKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557031-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120714919</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020281</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUSEDRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILATIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557032-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120605532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugdosagetext>1-2 TABLETS EVERY 6 HOURS WHILE AWAKE FOR 3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>3-4 DAILY FOR FEW MONTHS 2-3 YEARS AGO</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>1 CAPLET NIGHTLY AT BEDTIME FOR ABOUT 4 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>1 OCCASIONALLY FOR FEW MONTHS 2-3 YEARS AGO</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugdosagetext>1 CAPLET NIGHTLY AT BEDTIME FOR ABOUT 4 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>2 CAPLETS EVERY 6 HOURS WHILE AWAKE FOR 8 MONTHS 2-3 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>FOR 3 WEEKS 3-4 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557034-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120709983</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557035-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120706803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>THRICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NON STEROIDAL ANTI-INFLAMMATORY DRUGS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>1 TO 2 MG, ONCE PER DAY AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20281</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557036-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020635</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557037-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-1092478</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugdosagetext>DOSE ADJUSTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSE ADJUSTED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557038-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ROCHE-1091833</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL DISORDER FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557039-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16476BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557040-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BR-00829BR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNITIDAZIN</medicinalproduct>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>108584</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557041-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1090508</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugdosagetext>DOSE REDUCED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSE REDUCED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557042-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16356BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557046-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1089835</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION SUSCEPTIBILITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557047-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1090601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557048-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-1086183</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 6MG/KG</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 250MG/M2. DURATION: 6 COURSES</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>UNIT DOSE: 150MG/M2. DURATION: 6 COURSES</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557049-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-312610USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>076135</drugauthorizationnumb>
        <drugdosagetext>40 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557050-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1090608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.364</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557051-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-12P-013-0959186-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557052-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0955926-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCESSIVE MASTURBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOUR BLINDNESS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISINHIBITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIXOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBAL PREPARATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CYCLOTHYMIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557053-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-ROCHE-1093237</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557054-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1089340</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERTUZUMAB</medicinalproduct>
        <drugbatchnumb>BN0540937</drugbatchnumb>
        <drugauthorizationnumb>009900</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:29/JUN/2012, LOADING DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>BNH4071</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:29/JUN/2012, LOADING DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERTUZUMAB</medicinalproduct>
        <drugbatchnumb>BN0540937</drugbatchnumb>
        <drugauthorizationnumb>009900</drugauthorizationnumb>
        <drugdosagetext>MAINTANANCE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>BN0540938</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:29/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>BNH4071</drugbatchnumb>
        <drugdosagetext>MAINTANANCE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557055-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1091159</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557056-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120713946</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugdosagetext>LOXEN L.P.50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>TERALITHE L.P 400MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDYS</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557057-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>019927</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557058-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>073585</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557059-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS-JNJFOC-20120710875</companynumb>
    <primarysource>
      <reportercountry>SERBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557060-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20120609053</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugauthorizationnumb>009925</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557061-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1094082</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGE-RELATED MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557062-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1091156</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557063-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110212</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-1093714</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENOMETRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557064-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557065-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1104FRA00077</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT-MYCOSIS FUNGOIDES</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110228</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT-MYCOSIS FUNGOIDES</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110403</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>18.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110228</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRETERAX (INDAPAMIDE (+) PERINDOPRIL ERBUMINE)</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>36.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110321</drugstartdate>
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        <drugenddate>20110406</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557066-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557067-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1092637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELL CEPT</medicinalproduct>
        <drugauthorizationnumb>50723</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557068-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-051510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CONTRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugindication>ANGIOGRAM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugindication>ANGIOGRAM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugindication>ANGIOGRAM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugindication>ANGIOGRAM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugindication>ANGIOGRAM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557069-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120715</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1091227</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557070-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009268</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BANALON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557076-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>50758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557077-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-BAYER-2012-077070</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugauthorizationnumb>200179</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557078-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-001170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPHELIDES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugindication>MUSCULAR WEAKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM IN UNSPECIFIED DRUG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugindication>DISORIENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>20 U, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugdosagetext>90 MG, QD</drugdosagetext>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW RELEASE IRON</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040521</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
        <drugdosagetext>667 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENVELA</medicinalproduct>
        <drugdosagetext>QID WITH MEALS</drugdosagetext>
        <drugindication>DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugdosagetext>15 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060602</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROVITE [VIT C,VIT H,B5,B12,B9,B3,B6,B2,B1 HCL]</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugindication>RENAL MASS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>1 U, TIW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557079-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1093452</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE 16/JAN/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADEINE (AUSTRALIA)</medicinalproduct>
        <drugdosagetext>30/500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557080-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1093810</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557081-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050930</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEAK EXPIRATORY FLOW RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557082-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-010817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOCINONIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557083-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ALLERGAN-1210210US</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>25.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110607</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>300 UNITS, UNK</drugdosagetext>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111122</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557084-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>73620</drugauthorizationnumb>
        <drugdosagetext>DATE OF LAST DOSE: 23/JUL/2012</drugdosagetext>
        <drugindication>THYROID CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557085-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557086-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557087-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557088-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557089-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2012184320</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>382</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugauthorizationnumb>021234</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>391</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>25 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIATEC COMP</medicinalproduct>
        <drugdosagetext>2.5 MG/12.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>4 IU DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>400 PG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>850 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557090-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557091-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012186004</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557092-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012061484</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110909</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>16 UNITS, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110918</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MITRAL VALVE STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110831</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINK</medicinalproduct>
        <drugdosagetext>5 UG, ALTERNATE DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110913</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>25 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>0.5 G, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPENEM AND CILASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>0.5 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGIN</medicinalproduct>
        <drugdosagetext>9000 UNITS, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110909</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APIDRA</medicinalproduct>
        <drugdosagetext>4 UNITS, 3X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110918</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557093-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2004061434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EARLY RETIREMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>008762</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19650101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557094-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012184368</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557095-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557096-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012136222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>V111808</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557097-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093880</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOCEPREVIR</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>010001</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557098-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1094167</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARASMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557099-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1210149US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OZURDEX</medicinalproduct>
        <drugauthorizationnumb>022315</drugauthorizationnumb>
        <drugdosagetext>0.7 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL VEIN OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557104-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ID-ROCHE-1093942</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557105-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557106-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557107-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110314</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557108-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ROCHE-1094176</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557109-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110408</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557110-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-1094658</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557111-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062549</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugbatchnumb>26267</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>087757</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557112-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1094233</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557113-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1094369</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE ON 03/JUL/2012 (ROUTE OF ADMINISTRATION AS PER PROTOCOL)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557114-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557115-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-EISAI INC-E7389-02719-SPO-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557116-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA007269</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>130 MICROGRAM, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>73</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557117-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA005869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
        <drugbatchnumb>1G3181</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557118-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557119-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557120-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1094785</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557124-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-0808501US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.376</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080205</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>100 MG, 2 TABS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>200 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1 CAPSULE, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>100 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>2 TABLETS, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSKINESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25 MG, QPM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN SL</medicinalproduct>
        <drugdosagetext>0.125 MG, Q12H</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>SECRETION DISCHARGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>1 SPRAY EACH NOSTRIL, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugdosagetext>100 UNITS, SINGLE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080304</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>75 MG, QPM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557125-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557126-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00S54</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557127-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-067146</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPLENIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC PSEUDOCYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 3 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYFUL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557128-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557129-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080201</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557130-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ROCHE-1094546</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>HAIRY CELL LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557131-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950959-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557132-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-12P-013-0959763-00</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZINE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLAVIT</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557133-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UY-ABBOTT-12P-168-0940238-00</companynumb>
    <primarysource>
      <reportercountry>URUGUAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557134-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012149023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557135-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2004096028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557136-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012178673</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARGATROBAN</medicinalproduct>
        <drugauthorizationnumb>020883</drugauthorizationnumb>
        <drugdosagetext>100 MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPARIN-INDUCED THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557138-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012177607</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PNEUMOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557139-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012184355</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE PACING ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557140-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012175506</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ZYGOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>050467</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557141-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-PFIZER INC-2012167482</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONAT ACCORD</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL LA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugauthorizationnumb>008697</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS-D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TATRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557142-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012172376</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557143-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012165513</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG/DAY OR 25 MG/DAY ON AN ALTERNATE-DAY BASIS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY (3RD COURSE)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY (1ST AND 2ND COURSES)</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557144-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012182372</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557145-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012175762</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>50162</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>16MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK, THRICE IN A DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY; STRENGHT 250/125</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557146-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012173655</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557147-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012168671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>010402</drugauthorizationnumb>
        <drugdosagetext>UNK, MONTHLY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>0.625 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557148-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.701</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN SUBLINGUAL</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>12 UG, ONCE IN THREE DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE/VITAMIN D</medicinalproduct>
        <drugdosagetext>630 MG/500 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>200 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>88 UG, UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN/GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>1200/1500MG ,UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
        <drugdosagetext>90 MCG INHALER</drugdosagetext>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557149-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012182232</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557150-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012180220</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20988</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugdosagetext>80MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugdosagetext>160 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>3 GM (1 GM,3 IN 1 D)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>310</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557151-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110214</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557152-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012167057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOTROL XL</medicinalproduct>
        <drugauthorizationnumb>020329</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>VEIN DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557153-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012175154</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>THE STARTER PACK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557154-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012168876</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050797</drugauthorizationnumb>
        <drugdosagetext>2000 UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA MYCOPLASMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557155-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557156-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012171548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>B10659930</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>B10659930</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557157-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557158-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094649</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557163-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100316</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557164-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012179987</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557165-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012174893</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557166-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012182201</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXEMESTANE</medicinalproduct>
        <drugauthorizationnumb>20753</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>324</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557167-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012170158</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLISTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
        <drugauthorizationnumb>062682</drugauthorizationnumb>
        <drugdosagetext>1 G, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 DF, THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557168-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012168806</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSENTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080317</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557169-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012182151</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
        <drugauthorizationnumb>21437</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMERIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EUPRESSYL</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557170-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE INFECTION FUNGAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, 2X/WEEK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557171-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP032589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAPILLOMA VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557172-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
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      <senderorganization>FDA-Public Use</senderorganization>
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      <reaction>
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        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
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      <drug>
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        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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        <medicinalproduct>XOLAIR</medicinalproduct>
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        <reactionmeddrapt>APNOEA</reactionmeddrapt>
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        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
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        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
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        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011US21324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>150 MG, EVERY 56 DAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC URTICARIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>911</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>150 MG, EVERY EIGHT WEEKS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CRYOPYRIN ASSOCIATED PERIODIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557186-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA056212</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557187-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FANAPT</medicinalproduct>
        <drugauthorizationnumb>022192</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557188-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE055991</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557189-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US064210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG, PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>60 MG, PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557190-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557191-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011US25106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRACHIAL PLEXOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>70 MG, Q12H</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>20 MG, QID</drugdosagetext>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110420</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557192-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE064402</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMIPRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>10 GTT, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTEX</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557193-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012PL064142</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
        <drugauthorizationnumb>017962</drugauthorizationnumb>
        <drugindication>PROLACTINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557194-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US005978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERIPHERAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGLE CLOSURE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugdosagetext>25 MG,  1 PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557195-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110216</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557196-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557197-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP060464</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557199-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP036805</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPHOSPHATASAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG, 4 TIMES PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>125 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120422</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120415</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557200-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US064825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFANTILE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>3 MG/KG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>14 MG/KG/DAY</drugdosagetext>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>9 MG/KG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>6 MG/KG/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557201-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012EC065823</companynumb>
    <primarysource>
      <reportercountry>ECUADOR</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugauthorizationnumb>021014</drugauthorizationnumb>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557202-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011US05088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557203-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065017</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557204-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US06031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN RECEPTOR ASSAY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOCYTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACANTHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA NITROGEN/CREATININE RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BAND NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTERNAL EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QINOLON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG / Q WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /UNK/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>1300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMVIR                                  /NET/</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>5%</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>10 MG,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>0.12%</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>15 MG/5ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK / TID PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX                                  /USA/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>1 GM</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL 500-D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
        <drugdosagetext>400 MG / BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG / TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG / QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-GEN</medicinalproduct>
        <drugdosagetext>8.65 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>0.1 %</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.5 MG / BID PRN</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>400 MG / 1-2 Q8HRS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/325</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>100 MG / QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557205-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA51019</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557206-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CH065321</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPOTUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPAMPERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557208-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011IE69978</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUMPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHORRHEXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION SICKNESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110723</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557209-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557210-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2006JP00821</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050810</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, PER ADMINISTRATION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050511</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, PER ADMINISTRATION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, PER ADMINISTRATION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050805</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugdosagetext>2.5 MG, TID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050810</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, PER ADMINISTRATION</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050702</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050630</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLEURAL EFFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050705</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557211-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065966</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>1 DF, EVERY DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557212-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT062778</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557213-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE065842</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYARTERITIS NODOSA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>600 MG, PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557214-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT050153</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>572</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557215-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA005946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLOR-TRIMETON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557216-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1095275</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST HERPETIC NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS VIRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FCR REGIMEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEMTUZUMAB</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GCSF OR GMCSF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557217-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORICIDIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557218-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1091242</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 09/APR/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATRIUMHYDROGENCARBONAT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557219-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN040465</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD ABNORMALITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557220-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB065747</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEFOPAM</medicinalproduct>
        <drugdosagetext>30 MG, 60 DF (60 ? 30MG TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>50 MG, 14 DF (14 ? 50MG DICLOFENAC TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557221-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTURNA</medicinalproduct>
        <drugbatchnumb>F0100</drugbatchnumb>
        <drugauthorizationnumb>022217</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTURNA</medicinalproduct>
        <drugbatchnumb>F0100</drugbatchnumb>
        <drugauthorizationnumb>022217</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557223-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004193</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557224-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CN91786</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557225-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012HU044042</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO ADRENALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COVEREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPRESSAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557226-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN046155</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTERIXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAMMONAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557227-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2011AU06658</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110408</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>37.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALMA</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557228-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU059795</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLOXYL WITH SENNA</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF(320 MG VAL/5 MG AMLO)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACU-VISION</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF(160 MG VAL/5 MG AMLO)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557229-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012US011178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
        <drugtreatmentduration>1077</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557230-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US08722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC EROSIVE GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPHTHALMOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED OESOPHAGEAL WEB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOACANTHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO MENINGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGRANEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557231-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557234-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE304866</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEC (CANADA)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE/ACETAMINOPHEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-TUBOCURARINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-CAL</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557236-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLOW SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111128</drugenddate>
        <drugtreatmentduration>137</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557237-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066055</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF (160/12.5 MG), UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557238-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065919</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>1 DF, QD (10 MG)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557239-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US011781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0013/ S0019</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL CD</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPROX</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMPRIDINE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557240-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE002971</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>1 DF/ DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.4 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>95 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>16 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557241-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US009090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDOL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557242-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0013A</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1.5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557243-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012US011181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>897</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557244-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003385</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557245-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE065879</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557246-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP061947</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS LUPUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557247-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB002156</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE BUTYLBROMIDE</medicinalproduct>
        <drugdosagetext>900 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>2.4 G, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557248-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT064819</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>19201</drugauthorizationnumb>
        <drugdosagetext>75 MG/3 ML</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUSCORIL</medicinalproduct>
        <drugdosagetext>4 MG/2 ML</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557250-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL</medicinalproduct>
        <drugbatchnumb>420412</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557252-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066051</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557253-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2007JP02271</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG,  DILURTED TO 100 ML</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061102</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>20 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTIAM HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061111</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAFAMOSTAT</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELASPOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557254-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US012902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID, ALTERNATIVE 28 DAYS</drugdosagetext>
        <drugindication>CYSTIC FIBROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>3 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTEN</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, QMO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557255-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US005845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FANAPT</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugbatchnumb>F0140</drugbatchnumb>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugbatchnumb>F0139</drugbatchnumb>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557256-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE290971</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>138.47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUFFOCATION FEELING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S00777,S0077</drugbatchnumb>
        <drugdosagetext>300 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S00777,S0077</drugbatchnumb>
        <drugdosagetext>300 MG,3/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557257-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557258-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugbatchnumb>14271C</drugbatchnumb>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>7 ML, ONCE</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120731</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557259-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>13076 D</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557260-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.3 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557261-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMAGING PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMAGING PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557262-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-053817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000413</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557264-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1094947</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557265-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557267-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE47794</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>018240</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557268-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2012SE51644</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARVELON 28</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMOVO</medicinalproduct>
        <drugauthorizationnumb>022511</drugauthorizationnumb>
        <drugdosagetext>375 MG / 20 MG, ONE EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557269-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-734015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIUMBILICAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19861231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557270-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-787552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557271-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557272-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>138.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 UNITS, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557273-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-PFIZER INC-2012174340</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE TIMING UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557274-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012183766</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557275-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012174892</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>97</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557276-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012184013</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557277-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557278-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557279-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061107</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557280-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1094974</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557281-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2012SE51841</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557282-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMOVO</medicinalproduct>
        <drugauthorizationnumb>022511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557283-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50431</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>020768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557284-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP034065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugbatchnumb>905306</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557285-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-009507513-1207CHE010524</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIPLANT</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MICROGRAM, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIORIN N</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>1.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIPEG</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KCI PHARMA MEGAVIT</medicinalproduct>
        <drugdosagetext>10 MMOL, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557286-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557287-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557288-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP023955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTORPHANOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557298-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557299-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>3 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK,DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugdosagetext>1 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EMOTIONAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557300-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugauthorizationnumb>019668</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557301-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012183687</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEDIATRIC ADVIL</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugdosagetext>3 INTAKES ON 48 HOURS</drugdosagetext>
        <drugindication>VARICELLA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557302-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012179469</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>500 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIDANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557303-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557304-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557305-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012183951</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>DECREASED THE DOSAGE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557306-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PA-PFIZER INC-2012182476</companynumb>
    <primarysource>
      <reportercountry>PANAMA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557307-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugauthorizationnumb>021234</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557308-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2012183422</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 TABLET IN THE MORNING AND 1 TABLET IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 TABLET PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557309-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2012183929</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557310-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2012183307</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINITIS TRICHOMONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, CYCLIC (4 WEEKS ON/ 2 WEEKS OFF)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557311-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012182574</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>2 TABLETS DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK (STRENGTH 1MG)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
        <drugdosagetext>20 DROPS DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557312-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012183427</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557313-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012165155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>10 MEQ, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>1.65 %, 4X/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557314-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-CID000000002071479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557315-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CS-01114IG</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugdosagetext>25/200 MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557316-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BR-00833BR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODYNAMIC INSTABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557317-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-10834NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557318-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1095088</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>IRIS NEOVASCULARISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557320-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-391310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE REPORTED AS ONE INJECTION PER WEEK.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050109</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557321-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-GNE322676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>19676</drugauthorizationnumb>
        <drugdosagetext>.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557322-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-750055</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>FORM: VIAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTELOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557323-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS SEASONAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugdosagetext>TWISTHALER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557324-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ALLERGAN-1210360US</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>FACIAL SPASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557325-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1095046</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557326-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557327-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557328-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060907</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557329-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1094949</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557330-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557331-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-703485</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTI-THYMOCYTE GLOBULIN NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557332-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPRELSA</medicinalproduct>
        <drugauthorizationnumb>022405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557333-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557334-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52088</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>28185</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557339-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557340-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20110203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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  </safetyreport>
  <safetyreport>
    <safetyreportid>8557341-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE314952</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,NOT REPORTED,NOT REPOR</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557342-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557343-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557344-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012171046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.354</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>F12772</drugbatchnumb>
        <drugauthorizationnumb>4782</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, DAILY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>AUTOIMMUNE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557345-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557346-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012151097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557347-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012181523</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTUSS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557348-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012155170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>250 MG DAILY ON SATURDAYS AND SUNDAYS AND 120 MG DAILY ON THE REST OF DAYS</drugdosagetext>
        <drugindication>VISUAL IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>50 UG, DAILY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>150 UG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>100 UG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>75 UG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>200 UG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557349-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012181310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>FOLLICLE-STIMULATING HORMONE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD LUTEINISING HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD ANTIDIURETIC HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, 7/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557350-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012163843</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557351-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012153682</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>16.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.6MG OR 0.75MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BODY HEIGHT BELOW NORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>0.83 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557352-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012155067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugauthorizationnumb>021134</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557353-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012181951</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110909</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110226</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557354-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012181481</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557355-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012184975</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>60 DROPS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMAZINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>45 GTT, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>375 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557356-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557357-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012182523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORDETTE-28</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.6 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557358-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557359-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557360-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012180761</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557361-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012155128</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE TIMING UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE DURING BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557362-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012183561</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557363-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012170541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOURETTE'S DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557364-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012176200</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110512</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>4MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>25MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugdosagetext>150MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>2MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN D</medicinalproduct>
        <drugdosagetext>0.25MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>2.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>330MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>2.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557365-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158339</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETALOC ZOK ^ASTRA^</medicinalproduct>
        <drugdosagetext>47.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557366-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012163983</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557367-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158158</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557368-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.351</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>175 MG,DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>AGORAPHOBIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugindication>AGORAPHOBIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557369-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-727087</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE FORM: ENTERIC COATING DRUG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100810</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOSHA-JINKI-GAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMINE CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557370-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1095259</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557371-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557372-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MSD-1207ESP012992</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugdosagetext>2 COMPRIMIDOS/8 HORAS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557373-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557374-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>021249</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1089055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>10-20</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE 12/JUN/2012</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557376-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557377-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2012S1014539</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>077657</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557378-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557383-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-349693ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>062497</drugauthorizationnumb>
        <drugdosagetext>200 MILLIGRAM;</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557384-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-062273</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugauthorizationnumb>022064</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURAX</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA</medicinalproduct>
        <drugdosagetext>LOTION ONE TIME DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557385-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP027224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugdosagetext>200 ?G, QD</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugdosagetext>100 ?G, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557386-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557387-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201201915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>078907</drugauthorizationnumb>
        <drugdosagetext>600 UG, QID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>078907</drugauthorizationnumb>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL                           /00393701/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557388-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN NEGATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>3032601</drugbatchnumb>
        <drugauthorizationnumb>077154</drugauthorizationnumb>
        <drugdosagetext>100 MCG/HR Q 48 HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugbatchnumb>1109000698</drugbatchnumb>
        <drugdosagetext>UP TO THREE TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>3032471</drugbatchnumb>
        <drugauthorizationnumb>077154</drugauthorizationnumb>
        <drugdosagetext>50 MCG/HR Q 48 HR</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557389-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202470</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>078907</drugauthorizationnumb>
        <drugdosagetext>1 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557390-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557392-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SHIRE-CQT2-2010-00005</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
        <drugdosagetext>3 MIU, THREE TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030313</drugenddate>
        <drugtreatmentduration>298</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>250 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ANAGRELIDE HCL</medicinalproduct>
        <drugauthorizationnumb>20333</drugauthorizationnumb>
        <drugdosagetext>.5 MG, 2X/DAY:BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091007</drugenddate>
        <drugtreatmentduration>857</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugdosagetext>17.5 MG, MONTHLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557393-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351178USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>3380230A</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557396-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2012-02462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.737</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugauthorizationnumb>021977</drugauthorizationnumb>
        <drugdosagetext>30 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugauthorizationnumb>021977</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557397-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52115</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BICYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE BASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR SODIUM</medicinalproduct>
        <drugindication>PNEUMONIA CYTOMEGALOVIRAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENALIN IN OIL INJ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOCARDITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSFOMYCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557398-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010810</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557400-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008844</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN OD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557401-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012184084</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugbatchnumb>125</drugbatchnumb>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>1 TABLET (100 MG) ONCE DAILY (EVERY 10 DAYS TEMPORARILY STOPPED THEN RE-STARTED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090322</drugenddate>
        <drugtreatmentduration>1507</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557402-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012184107</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557403-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012151060</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.819</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>12.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugbatchnumb>C1025</drugbatchnumb>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION URGENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugindication>CYSTITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-PFIZER INC-2012173823</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557406-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2012180957</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>018668</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557407-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0081147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019516</drugauthorizationnumb>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557408-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1061197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY WAS 5 TO 6 TIMES</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19880101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557409-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHINALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557410-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557411-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0933495-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557412-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959384-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>141502E</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557413-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0944643-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557414-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0917413-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557415-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21660-12071230</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>021660</drugauthorizationnumb>
        <drugdosagetext>180 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTECADIN</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110228</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELDEST</medicinalproduct>
        <drugdosagetext>300 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111003</drugenddate>
        <drugtreatmentduration>236</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150-300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>271</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>180 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>180 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557416-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-12P-008-0959673-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BILIARY CIRRHOSIS PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557417-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1061223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19861029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19870401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19881024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557418-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52106</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32084</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>ALTERNATING OF 5 MG AND 15 MG EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557421-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557422-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, SINGLE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557423-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201205000306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXIRON</medicinalproduct>
        <drugauthorizationnumb>022504</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557424-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RECALL PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPEUTIC RADIOPHARMACEUTICALS</medicinalproduct>
        <drugdosagetext>UNK UNK, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557425-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A937392A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557426-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.19</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                                 /SCH/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX HFA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557427-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA201207006911</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTHAVENT</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 50/50</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>42 U, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>850 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557428-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007792</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201207006566</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORVASAL</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOXYMETHYL PENICILLIN</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557431-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201207008019</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557432-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR201207008474</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557433-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201207001965</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110910</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557434-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXIRON</medicinalproduct>
        <drugauthorizationnumb>022504</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557435-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201206000607</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORFINA                            /00036301/</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETASON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMOPRIDA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>225895A</drugbatchnumb>
        <drugdosagetext>157 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>225895A</drugbatchnumb>
        <drugdosagetext>157 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugbatchnumb>A974195</drugbatchnumb>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1412 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugbatchnumb>A974195</drugbatchnumb>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1412 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201204004029</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>4 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODINE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>0.1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICOOL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>550 MG, UNK</drugdosagetext>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>40 ML, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugdosagetext>3 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557438-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201205000155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>139.68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A877226A</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>80 U, AT LUNCH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A907651C</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>90 U, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A877226A</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>80 U, EACH MORNING</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A877226A</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>65 U, AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557439-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-ELI_LILLY_AND_COMPANY-HU201207007111</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOMA BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557440-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIBENZOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>6 U, QD</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>12 U, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>10 U, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557441-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557442-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207001140</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAPLATIN AQ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>500 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557443-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007940</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROGRADUMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557445-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201207007977</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>14 IU, EACH MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>6 IU, EACH EVENING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557446-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201207008363</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557447-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557448-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201207006598</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>199</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557449-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351156USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557450-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENZYME-CERZ-1002174</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>C1176H02</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>3600 U, Q4W</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGALDRAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEURSIL</medicinalproduct>
        <drugdosagetext>600 MG, PER OS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTITOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557451-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREAS TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>75 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D                /01483701/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557456-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012173716</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>[AMLODIPINE BESILATE 5 MG]/ [ATORVASTATIN CALCIUM 40MG], 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557457-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012149562</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557458-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557459-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16444BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557460-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BR-00853BR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAYENTA</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1700 MG</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINVASTATINA</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEGILINA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557461-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-10339BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>20579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>6.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557462-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16292BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>2400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021530</drugauthorizationnumb>
        <drugdosagetext>7.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120421</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557463-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14234BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557471-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52087</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557473-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557474-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-342831USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557475-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA010291</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>021762</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557476-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA011117</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIPARINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557478-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0913628-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>THERAPY PAUSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEMETACIN</medicinalproduct>
        <drugdosagetext>90 MG NOS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>1000 MG NOS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557479-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-12P-143-0960817-00</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557480-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924390-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>081442E,141522E</drugbatchnumb>
        <drugdosagetext>STARTED WITH LOADING DOSE OF 160MG; FOLLOWED BY 80MG 2 WEEKS LATER</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>081442E,141522E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557481-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E7389-02116-CLI-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO UTERUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557482-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0935519-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYOMYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SACROILIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETORICOXIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY ENHANCEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557483-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ABBOTT-12P-144-0937117-00</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557484-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959363-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAPAROTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>7.5MG - 10MG QD</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557485-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951067-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557490-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-349674ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>TOOK LORAZEPINE FOR A LONG TIME, LATTERLY IN HIGH DOSES</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077048</drugauthorizationnumb>
        <drugdosagetext>TOOK CITALOPRAM FOR A LONG TIME, LATTERLY IN HIGH DOSES</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557491-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-047623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.503</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>500169</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG QD + 400 MG QD, CYCLE 9</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110718</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>325 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19901022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM</medicinalproduct>
        <drugdosagetext>440 MCG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DAILY DOSE 7000 U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101028</drugenddate>
        <drugtreatmentduration>543</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DAILY DOSE 175 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110410</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>4 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110730</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1000 U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>500151</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110512</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN EX</medicinalproduct>
        <drugdosagetext>ONE TSP, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110421</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>500163</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110527</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557492-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011128</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557493-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN000626</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOLONG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>200MG IN THE EVENING AND 400MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557494-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351183USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SECTRAL</medicinalproduct>
        <drugdosagetext>800 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061926</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>4 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugdosagetext>180 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557495-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-349775USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557506-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-349936ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061926</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557507-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2012SE52149</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557509-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557516-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC-E3810-05675-SOL-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugauthorizationnumb>020973</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557517-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-003868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>210</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLUVEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>01770D</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>143 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110107</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557518-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557519-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557520-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2012SE52129</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTISPASMODIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE (PRISOLEC)</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557521-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012113341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.796</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTILATION PERFUSION MISMATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVASO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557522-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012150234</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557523-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012143180</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>017892</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557524-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012149289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.875</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557525-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012148540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHOLECYSTECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>0.9 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>37.5/25 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557526-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012123745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557527-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, STARTER PACK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091106</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557528-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012084606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>50 (NO UNITS PROVIDED), DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>20931</drugauthorizationnumb>
        <drugdosagetext>500 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120403</drugenddate>
        <drugtreatmentduration>449</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D2</medicinalproduct>
        <drugdosagetext>5000 IU, WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>10 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>50  (NO UNITS PROVIDED), DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>250 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 (NO UNITS PROVIDED), DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 (NO UNITS PROVIDED)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX</medicinalproduct>
        <drugdosagetext>400 (NO UNITS PROVIDED), 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>7.5/300 (NO UNITS PROVIDED), 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE/FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>500/50 (UNITS NOT PROVIDED), 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557529-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012145060</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557530-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012141240</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>P912402 E-02</drugbatchnumb>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugbatchnumb>P912402 E-02</drugbatchnumb>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1 TABLE, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557531-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012088880</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE COMPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557532-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK AND 1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557533-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012123774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB CRUSHING INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADONNA EXTRACT</medicinalproduct>
        <drugdosagetext>UNK, 3X/DAY</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>150 UG, DAILY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADONNA EXTRACT</medicinalproduct>
        <drugindication>ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557534-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-PFIZER INC-2012094302</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557535-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012123761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP TERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557536-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012123831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5/1 MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5/1 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557537-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012103402</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>1.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCYCLIDINE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557538-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012118159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557539-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012108389</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>21 MG, CYCLIC</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>1 MG, CYCLIC</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557541-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012124953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPLANTABLE DEFIBRILLATOR INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTAZIDE</medicinalproduct>
        <drugauthorizationnumb>012616</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1/2 DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557542-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1090928</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:09/JUL/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIVE LUBRICANT EYE DROPS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOGRASTIM</medicinalproduct>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:09/JUL/2012</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>30/500; 120MG/4G</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:09/JUL/2012; MAINTENANCE FOR 24 MONTHS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557543-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>CHANTIIX STARTING PACK AND 1MG MISCELLANEOUS (SAMPLES)</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080812</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557544-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012137306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.224</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTAID</medicinalproduct>
        <drugindication>LACTOSE INTOLERANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, FOR 42 DAY CYCLE (CYCLE 1)</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>CYCLE 2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557545-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-1091245</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>DAILY DOSE - 880 UI</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENOUS INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBONATO CALCICO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557546-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1090509</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557547-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE05703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>ONE PUFF DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUGAR PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/ 4.5 DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>TWO PUFF DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>TWO PUFFS TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557548-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955897-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.768</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS INTERSTITIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBRIN D DIMER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>1 IN 1 DAY, NIGHTLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPOROL</medicinalproduct>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557549-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927093-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERY ANGIOPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TITRATED TO 3000MG PO QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TITRATED FROM 500 QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557550-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-ABBOTT-12P-216-0959888-00</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZALDIAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>325 MG/ 37.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>12003</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>100 MG LEVODOPA + 25 MG BENSERAZZIDE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KORDOBIS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>100 MCG SALBUTAMOL</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557553-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-EISAI INC-E3810-05670-SPO-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KRENOSIN</medicinalproduct>
        <drugadministrationroute>022</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugadministrationroute>013</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISIPAQUE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>022</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugauthorizationnumb>020973</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REOPRO</medicinalproduct>
        <drugadministrationroute>022</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557554-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE25833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILENOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557555-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21660-12072348</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGOTRACHEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>021660</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557556-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>LEFT VENTRICULAR DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557564-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-074715</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TELANGIECTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557565-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE38854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRANIOCEREBRAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugdosagetext>ZOMIG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugdosagetext>TAKES TWO TO FOUR TABLETS A DAY SOMETIMES DEPENDING ON HER HEADACHE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557566-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ARROW-2012-10578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>92471915</drugbatchnumb>
        <drugauthorizationnumb>076709</drugauthorizationnumb>
        <drugdosagetext>2 - 100MCG PATCHES ^ARE OVER THE ANTERIOR AND LATERAL RIGHT HIP^ (PER MEDICAL EXAMINER REPORT)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557567-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JUTA-2012-13252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOID MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076179</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAPLASTIC ASTROCYTOMA</drugindication>
        <drugtreatmentduration>4380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557568-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-WATSON-2012-13045</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>018832</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557569-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-WATSON-2012-13046</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>018832</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557570-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-12967</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>077137</drugauthorizationnumb>
        <drugdosagetext>250 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557571-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-WATSON-2012-13044</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070435</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557572-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-WATSON-2012-13214</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>021574</drugauthorizationnumb>
        <drugdosagetext>3 G, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557573-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-13028</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>450 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076336</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557574-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-WATSON-2012-13205</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>021574</drugauthorizationnumb>
        <drugdosagetext>2 G, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557575-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-WATSON-2012-13043</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>80521</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557576-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-WATSON-2012-13047</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>018832</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2012-10808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPRISONMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEROIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK DOSE 3 - 4 QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugauthorizationnumb>040148</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK DOSE, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>HAEMORRHOIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugauthorizationnumb>040148</drugauthorizationnumb>
        <drugindication>HAEMORRHOIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>UNK DOSE, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK DOSE BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK DOSE QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>40148</drugauthorizationnumb>
        <drugdosagetext>UNK, 6 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557579-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-11755</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076336</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>450 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557580-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ARROW-2012-12706</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076549</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557581-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-WATSON-2012-13213</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>021574</drugauthorizationnumb>
        <drugdosagetext>1.5 G, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557582-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-WATSON-2012-13037</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>018832</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557583-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-12968</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>077671</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557584-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-WATSON-2012-13212</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>021574</drugauthorizationnumb>
        <drugdosagetext>3 G, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557585-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-WATSON-2012-13042</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>080521</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557586-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WATSON-2012-11719</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAFLO</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>22206</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDIMMUNE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIPROSTAT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557587-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-WATSON-2012-12811</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLSAURE</medicinalproduct>
        <drugdosagetext>0.8 MG, DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NEURAL TUBE DEFECT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>077034</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BORDERLINE PERSONALITY DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>150 MG DAILY REDUCED UNTIL GW26, THEN STOPPED</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BORDERLINE PERSONALITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557588-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ARROW-2012-11551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076794</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>076794</drugauthorizationnumb>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>076794</drugauthorizationnumb>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>SYSTEMIC CANDIDA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557589-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012051298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557590-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557591-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557592-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012029633</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120129</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557593-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010146090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>272</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIFUNGAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557594-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>0.625 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19760101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557595-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557596-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012034589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.982</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF BLOOD FLOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>B10153035</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>ONE AND HALF TABLET (75 MG), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>3 MG, 2X/DAY</drugdosagetext>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>B10153035</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG, 1X/DAY</drugdosagetext>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>BURSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>TENDONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557597-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557599-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-033-0073-M0100006</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980710</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557600-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE25110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHAYME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>STANDARD AMOUNT ONCE A DAY, AS NEEEDED 2 TIMES A DAY,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>2 PUFF ONCE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUSTENEX (PROBIOTIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER CHOICE (PROBIOTIC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>2 PUFF TWICE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FOR LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG AT BEDTIME AND 0.25 MG 3 TIMES IN A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC LORTAB</medicinalproduct>
        <drugdosagetext>7.5 TO 500 MG AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C WITH ROSEHIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CALTRATE PLUS D</medicinalproduct>
        <drugdosagetext>600 TWICE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE NASAL</medicinalproduct>
        <drugdosagetext>0.025 MGC, USP 0.025%.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1500 IU, FREQUENCY UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMOLOG R</medicinalproduct>
        <drugdosagetext>AFTER DINNER BETWEEN 6 TO 10 UNITS DEPENDING ON HER FOOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NHP</medicinalproduct>
        <drugdosagetext>24 OR 25 AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugdosagetext>1000 MG 4 TIMES A DAY FOR OCCAISONAL USE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN AND MINERAL PRENATAL SUPPLEMENT W/ FOLIC ACID CAP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557601-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012042466</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557603-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00977UK</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TASTE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugbatchnumb>106973</drugbatchnumb>
        <drugauthorizationnumb>21527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557604-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16584BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557605-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16529NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557606-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE37930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557607-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206008166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISPRO</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>5 U, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN BASAL ANALOG III (LY2605541) SUB</medicinalproduct>
        <drugdosagetext>26 U, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557608-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-C5013-10102615</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>1000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>144 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>30/500MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>144 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>120 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557609-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-CELGENEUS-129-21880-12072137</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557610-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557611-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1013134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>EVERY 4 TO 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077042</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVER SULFADIAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557612-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557613-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-TEVA-349959ISR</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugauthorizationnumb>075493</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EWING'S SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557614-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1013134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVER SULFADIAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>EVERY 4 TO 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557615-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE51601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERCEPTED DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557616-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>21857B</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>125 ML, ONCE</drugdosagetext>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557617-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2011S1008316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10MG/325MG; ONE EVERY 4-5 HOURS AS NEEDED WITH A MAX OF 5 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>ONE - THREE TIMES PER DAY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20MG/25MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>EVERY 8 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
        <drugdosagetext>SAMPLE BOX WITN NO NAME OR DOCTOR FOUND WITH OTHER MEDICATIONS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>ON 12 HOURS OFF 12 HOURS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugdosagetext>1 -2  PER DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557618-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2011S1020269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugdosagetext>CHANGE Q3D</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugdosagetext>CHANGE Q3D</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557620-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE14917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>HALF THE PILL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>TAKING TWO TABLETS AS PRESCRIBED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>TAKING ONE TABLET INSTEAD OF TWO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557621-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557622-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1019874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10MG/325MG; 1-2 EVERY SIX HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE PAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>SAMPLES</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557623-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2012SE52163</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROLIN SPRAY</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557624-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557625-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-011010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.848</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557626-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010960</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557628-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557629-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2008UW24954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557630-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE07612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557631-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557632-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201201392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>1200 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>12.5 MG, QID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>160 MG/5ML, 480 MG Q 4 HRS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG EXC 2.5MG Q MON/FRI</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>48 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>145 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD DEPENDING ON BP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>60 MG/0.6 ML, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>25 MG/ML, Q 4 HRS PRN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>PRN25 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>25 MG, Q 6 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2 MG, Q 4 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7.5-500 MG/15ML, Q 4-6 HRS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.3 MG/24HR, WEEKLY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugdosagetext>500MG/5 ML, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>15 MG/1.5ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557633-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-1006060</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORADUR MITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110930</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EGILOK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPRILAN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENELBIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557634-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1092553</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELNIQUE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557635-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1092298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557636-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201200918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557637-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201201228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557638-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NONSPECIFIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, QD ON WEDNESDAY AND FRIDAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>0.5 MG, BID TAKE 2 CAPS IN AM + 1 CAP IN PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>8.6 MG, QD QHS OTC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 TAB QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>325 MG, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>7.5 MG, QD ON SUNDAY, MONDAY, TUESDAY, THURSDAY, AND SATURDAY (5 MG TAB)</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD MAGNESIUM DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD QHS OTC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557639-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201201131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS PLUS IRON</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, QW X 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557640-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, QW X 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557641-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201200347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>200 MG, Q 2 WEEKS</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>4 MG, Q 4 HRS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLATE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>80-4.5 MCG, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557642-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>1200 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557643-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1037944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMMONIUM LACTATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>73620</drugauthorizationnumb>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMMONIUM LACTATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111120</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMMONIUM LACTATE</medicinalproduct>
        <drugdosagetext>1 APPLICATION</drugdosagetext>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CICLOPIROX</medicinalproduct>
        <drugdosagetext>1 APPLICATION</drugdosagetext>
        <drugindication>TINEA CRURIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557644-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012182131</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>050467</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557645-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012166862</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557646-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012166864</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557647-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-UCBSA-055953</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugbatchnumb>60873</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMIZIDE</medicinalproduct>
        <drugdosagetext>20-50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMCINONIDE AND DIPROFALIC</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugbatchnumb>57215</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557648-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-1095343</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557649-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-TEVA-349974ISR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>022160</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557650-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557651-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE295852</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.056</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S008A,S0078B</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>500 UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S008A,S0078B</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S008A,S0078B</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S008A,S0078B</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugdosagetext>200 UNK, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557652-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE LASER SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DILATION AND CURETTAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>0-2 UNITS, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>10-20 UNITS, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557653-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557658-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557659-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201207005293</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2/M</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557660-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557661-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557662-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ELI_LILLY_AND_COMPANY-CN201205007936</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557663-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201206006349</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLOW RESPONSE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATOSIL</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557664-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557665-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207006553</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557666-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207005932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELLARIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557667-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201201002952</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL GAMBLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTRAN 10</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091106</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557668-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207003648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELINGS OF WORTHLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEASONIQUE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL                            /00002101/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557669-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557670-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ASTRAZENECA-2012SE51476</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMOVO</medicinalproduct>
        <drugauthorizationnumb>022511</drugauthorizationnumb>
        <drugdosagetext>500/20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557671-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010955</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557672-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961191-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019732</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557674-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GT-ABBOTT-12P-069-0960391-00</companynumb>
    <primarysource>
      <reportercountry>COSTA RICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557675-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010992</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERYCIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN OD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUCROSE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557676-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0959737-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BORRELIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>10 MG NOS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557677-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0925738-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOTO</medicinalproduct>
        <drugdosagetext>2.5 GM DAILY DOSE</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>1 MG DAILY DOSE</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG DAILY DOSE</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN EXTRACT FROM INFLAMMATORY RABBIT SKIN INOCULATED BY VACCINIA VIRUS</medicinalproduct>
        <drugindication>CERVICOBRACHIAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MG DAILY DOSE</drugdosagetext>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugdosagetext>50 MG DAILY DOSE</drugdosagetext>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG DAILY DOSE</drugdosagetext>
        <drugindication>ALLERGY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMAPROST ALFADEX</medicinalproduct>
        <drugdosagetext>10 MCG DAILY DOSE</drugdosagetext>
        <drugindication>LUMBAR SPINAL STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>37.5 MG DAILY DOSE</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugdosagetext>80 MG DAILY DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG DAILY DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG DAILY DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557678-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>100-30</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557679-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12071085</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110426</drugenddate>
        <drugtreatmentduration>826</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557684-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-ASTRAZENECA-2012SE51475</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMOVO</medicinalproduct>
        <drugauthorizationnumb>022511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557685-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE25881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557686-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52377</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>783</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE CONTRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugauthorizationnumb>021344</drugauthorizationnumb>
        <drugdosagetext>250 MG/5 ML, 250 MG WITH UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557687-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-003050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557688-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2012-075672</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugindication>BLADDER ADENOCARCINOMA STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugbatchnumb>21040A</drugbatchnumb>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557689-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012120434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1 TAB AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS DIRECTED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557690-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012169171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557691-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070519</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012182859</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 MG EVERY 12 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>20+12.5 MG EVERY 24 HOURS</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG EVERY 24 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG EVERY 24 HOURS</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557692-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.365</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAFFEINE CONSUMPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugbatchnumb>BI20299</drugbatchnumb>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>35 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugbatchnumb>E69175S</drugbatchnumb>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557693-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012156062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557694-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557695-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010088300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG,DAILY</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>1 TO 2 MG, DAILY</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>160 MG/ 4.5 MCG</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>2 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugbatchnumb>V100110</drugbatchnumb>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>100 MG,5X/DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>10 MG, 4X/DAY</drugdosagetext>
        <drugindication>DIVERTICULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557696-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557697-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012182625</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557698-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.923</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557699-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVASO</medicinalproduct>
        <drugdosagetext>54 UG, 4X/DAY  (DAILY DOSE 216 UG)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557700-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>638</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557701-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557702-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557703-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCROTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557704-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>085635</drugauthorizationnumb>
        <drugdosagetext>1 ML, EVERY 2 WEEKS</drugdosagetext>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557705-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012103451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50 MG AND 100 MG</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>SUICIDAL IDEATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>SUICIDAL IDEATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER KIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070726</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>SUICIDAL IDEATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>SUICIDAL IDEATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557706-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557707-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.585</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557708-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557709-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557710-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557711-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>T310A</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557712-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090821</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012184021</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557713-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012180926</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>QUINAPRIL/HYDROCHLOROTHIAZIDE 20/12.5 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557714-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012183860</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>[QUINAPRIL HCL 20]/[HYDROCHLOROTHIAZIDE 12.5 MG], 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557716-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557717-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100817</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185196</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557718-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557719-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0971178A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LUNG INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAMMAGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557720-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0801574B</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugdosagetext>18MG CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>300MCG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557721-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-GLAXOSMITHKLINE-B0816747A</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPRIM</medicinalproduct>
        <drugdosagetext>800MG TWO TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557722-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16576BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557723-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16578BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE ER</medicinalproduct>
        <drugdosagetext>20 MEQ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557724-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16581BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557725-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE18935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557726-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52611</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28311</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
        <drugauthorizationnumb>019888</drugauthorizationnumb>
        <drugdosagetext>20/12.5 MG/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557727-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE16603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRUSH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUDGEMENT IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557728-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CN-01629CN</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557729-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557733-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16279192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VUMON</medicinalproduct>
        <drugbatchnumb>0C60830</drugbatchnumb>
        <drugauthorizationnumb>020119</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557734-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>2.5 MG/3 ML (0.083 %), INHALE 3 ML (2.5 MG) BY NEBULIZATION, EVERY 8 HOURS PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugdosagetext>50 MCG, SPRAY 2 SPRAYS (100 MCG) IN EACH NOSTRIL ONCE DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALIRESP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>90 MCG, 2 PUFFS, EVERY 4-6 HOURS, PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, 2 PUFFS, TWO TIMES A DAY (IN THE MORNING AND EVENING)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557735-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557736-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SILENT MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557737-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52227</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24001</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>25 MG/2ML, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>1 COURSE WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugdosagetext>1 COURSE WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugdosagetext>200 DROPS DAILY +/- 50 DROPS AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557738-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE73230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557739-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-004031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>400 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557740-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012185671</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>47.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557741-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012183065</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.6 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557742-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012182811</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CROMOLYN SODIUM</medicinalproduct>
        <drugauthorizationnumb>18596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557743-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012184818</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>OLMESARTAN/HYDROCHLOROTHIAZIDE 20/12.5 MG 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>QUINAPRIL/HYDROCHLOROTHIAZIDE 20/12.5 MG 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN ZINC SUSPENSION</medicinalproduct>
        <drugdosagetext>28 UI IN THE AM, 16 UI  IN THE PM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557744-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011102419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugbatchnumb>C110201</drugbatchnumb>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557745-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012182030</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557746-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012176564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.982</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG, DAILY</drugdosagetext>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>6 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557747-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012181340</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>22021</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557748-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012051347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK THEN CONTINUING PACKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557749-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557750-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-004028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557751-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-004056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>AA3119A</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557752-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158342</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOCAL CORD NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557753-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557754-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012186054</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557755-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012051342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING PACK AND CONTINUOUS MONTHLY PACKS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557756-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012056748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557757-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557758-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012182078</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>NORMAL TENSION GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557759-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090528</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012184147</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>[OLMESARTAN MEDOXOMIL 20 MG/ HYDROCHLOROTHIAZIDE 12.5 MG], 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>120 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557760-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185733</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>1.8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH RETARDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATEMPERATOR</medicinalproduct>
        <drugdosagetext>200 MG, TWICE EVERY THIRD DAY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557761-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-ASTRAZENECA-2012SE51477</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS REACTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FASCIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557762-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE70938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557763-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE30304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557764-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-TEVA-349974ISR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>022160</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557765-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.756</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557766-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0961774-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYPO</medicinalproduct>
        <drugdosagetext>6000 I.E. /WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG /DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRRLECIT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>4 CAPSULES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG /DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG /DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557767-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0959722-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>50662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHARYNGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLERY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLANID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557768-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0961579-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugdosagetext>10 MCG PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557769-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0910733-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>102302E</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557770-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0961067-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TYPE I HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557771-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-12P-008-0961672-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18081</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUGH AND COLD PREPARATIONS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUGH AND COLD PREPARATIONS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INFLUENZA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557772-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0959762-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557773-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-12P-114-0934027-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>ANTIALLERGIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557774-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-12P-020-0943220-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557775-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE02032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557776-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2006UW00943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557777-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-349971ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>063009</drugauthorizationnumb>
        <drugdosagetext>100 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557778-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-1092407</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>CYCLE 1 DAY 2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>CYCLE 2 DAY 1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>CYCLE 1 DAY 2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>CYCLE 3 DAY 2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>CYCLE 1 DAY 2</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugdosagetext>DOSE 6000 UG/DAY FROM D6 TO D13 OF CYCLE 1,2 AND 3</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>CYCLE 2 DAY 2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARMUSTINE</medicinalproduct>
        <drugdosagetext>BCNU</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>CYCLE 1 DAY 3</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>CYCLE 1 DAY 2</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>CYCLE 3 DAY 2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>CYCLE 2 DAY 2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>CYCLE 1 DAY 1</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>CYCLE 1 DAY 1</drugdosagetext>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>CYCLE 3 DAY 1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557779-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1092330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557780-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIDRADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557781-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1091885</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557782-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE57655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557783-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE31564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557784-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG TWO PUFFS TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557785-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1068925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557786-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-062739</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE DELIVERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557787-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095313</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557788-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLASSIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557789-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-005439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050528</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557790-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557791-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557792-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557793-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557794-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557795-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2012-046212</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>250 ?G, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>12424A</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557796-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20081001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-007018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASYLOL</medicinalproduct>
        <drugauthorizationnumb>020304</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557797-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS-ASTRAZENECA-2012SE51359</companynumb>
    <primarysource>
      <reportercountry>SERBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>130</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPHYLLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOTEROL BROMIDE + IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>007</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020441</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>007</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557798-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0931908-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557799-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-12P-008-0962067-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557800-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948933-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>ONGOING AT TIME OF DIAGNOSIS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCOTNE</medicinalproduct>
        <drugdosagetext>5MG, Q4-6 HRS, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557801-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012180910</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557802-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557803-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557804-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>020768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557805-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-FOUGERA-2011FO000050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
        <drugbatchnumb>044E</drugbatchnumb>
        <drugauthorizationnumb>019137</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
        <drugbatchnumb>044E</drugbatchnumb>
        <drugauthorizationnumb>019137</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557806-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0724630A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>135.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557807-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0758398A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071215</drugenddate>
        <drugtreatmentduration>594</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557808-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0760280A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FUNCTION DISTURBANCE POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557809-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0782299A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557810-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0809146A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557811-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0809148A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557812-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0871139A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557813-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0871141A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557814-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0871174A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557815-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0876560A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080214</drugenddate>
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  <safetyreport>
    <safetyreportid>8557816-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0876569A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
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  <safetyreport>
    <safetyreportid>8557817-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557818-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0876582A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070512</drugenddate>
        <drugtreatmentduration>445</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060222</drugenddate>
        <drugtreatmentduration>177</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557819-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0876623A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557820-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0877049A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557821-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0889820A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557822-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0899179A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557823-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0925213A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557824-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0930445A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>R497969</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557825-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0965752A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>1ZP0063,2ZP0542</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557826-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120520</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0966580A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>125MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugdosagetext>57NGKM SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>20MG THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557827-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120309</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0969236A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2MGK CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120330</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>3.6MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557828-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0972915A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557829-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0979568A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE THROMBOCYTOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557830-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0982475A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.25MG FOUR TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR HFA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>200MGD PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR HFA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021254</drugauthorizationnumb>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>2PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MGD PER DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557831-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0983434A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>.25MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>80MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>3ML FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>15UNIT TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPROMELLOSE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557832-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0984963B</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFPODOXIME PROXETIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugauthorizationnumb>22291</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557833-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986356A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557834-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986357A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557835-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0986423A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERDESO</medicinalproduct>
        <drugauthorizationnumb>021978</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ECZEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557836-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986549A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021433</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557837-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986554A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>409</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>021254</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557838-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986566A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOCALISED INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022115</drugauthorizationnumb>
        <drugdosagetext>700MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557839-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0986612A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557840-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986977A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCLERODERMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557841-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986980A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557842-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986984A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>M100</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugdosagetext>30NGKM CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557843-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987201A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557844-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987423A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557845-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987582A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557846-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987599A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557847-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987721A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugdosagetext>90MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557848-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987781A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR COLOUR CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>2ZP0132</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557849-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987788A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>250MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557850-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987789A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMERGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557851-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987792A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557852-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987794A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557853-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987801A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557854-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0636759A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENITAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100307</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>GENITAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100304</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC OXIDE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>GENITAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100221</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557855-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100806</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0642797A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100322</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>22465</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100223</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557856-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0681024A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugbatchnumb>UNKNWON</drugbatchnumb>
        <drugauthorizationnumb>50564</drugauthorizationnumb>
        <drugdosagetext>2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISEPTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETANUS IMMUNE GLOBULIN (HUMAN)</medicinalproduct>
        <drugdosagetext>40IU SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100911</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GINKOR FORT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2CAP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TETRAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100908</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100904</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100910</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557857-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GLAXOSMITHKLINE-B0746777A</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557858-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0799598A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAZITAXEL</medicinalproduct>
        <drugbatchnumb>D1 C 518</drugbatchnumb>
        <drugdosagetext>35MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLOBULAR PELLET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>18703</drugauthorizationnumb>
        <drugdosagetext>50MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557859-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0809887A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557860-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0810517A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALFURAFINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2.5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557861-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0811382A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>1500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugdosagetext>3G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>.125MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>.9MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>.5MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHINESE MEDICINE</medicinalproduct>
        <drugdosagetext>6G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557862-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0811415A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHRONIC ACTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLIBRIS</medicinalproduct>
        <drugdosagetext>7.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557863-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0811743A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN CONCENTRATION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>2IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE (FLUCONAZON)</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>6MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557864-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0814320A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>.75MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020671</drugauthorizationnumb>
        <drugdosagetext>.5MGM2 PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557865-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0814501A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ELECTROLYTES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugauthorizationnumb>020487</drugauthorizationnumb>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARASENA-A</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557866-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-GLAXOSMITHKLINE-B0816106A</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLLIN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557867-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0818843A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RUBELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEASLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557868-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0819468A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROMACTA</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557869-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-GLAXOSMITHKLINE-B0819679A</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557870-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0072986A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MECHANICAL VENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT HYPEREXTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALDOXAN</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugdosagetext>2100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTIGA</medicinalproduct>
        <drugauthorizationnumb>022345</drugauthorizationnumb>
        <drugdosagetext>300MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500MG FIVE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORALHYDRAT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557871-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0076119A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHONDROITIN/GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>2700MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557872-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-Z0010648E</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>2000MGM2 CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557873-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-Z0016473A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557874-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557875-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>NA624</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557876-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>SINCE 30 YEARS</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557877-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110504</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugdosagetext>SINCE 6 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557878-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557879-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557880-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EGRIFTA</medicinalproduct>
        <drugbatchnumb>1B154A</drugbatchnumb>
        <drugauthorizationnumb>022505</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>LIPODYSTROPHY ACQUIRED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557881-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557882-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTRAZENECA-2012SE49626</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31436</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>22433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110529</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL DECONGESTION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120102</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110529</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120102</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557883-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557884-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2011SE31419</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>16/2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557885-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007060</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557886-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1208JPN000325</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>1, THE DIVIDED DOSE FREQUENCY IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>200 MG IN THE MORNING AND 400 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR TABLETS 10MG</medicinalproduct>
        <drugdosagetext>THE DIVIDED DOSE FREQUENCY IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>400 MG IN THE MORNING AND 200 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101016</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>0.5 THE DIVIDED DOSE FREQUENCY IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
        <drugtreatmentduration>344</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557887-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA04196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUCTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PECTUS CARINATUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugindication>EX-TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>500/200</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>3019</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>35 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100224</drugenddate>
        <drugtreatmentduration>727</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>35 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100228</drugenddate>
        <drugtreatmentduration>2001</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE + D</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EX-TOBACCO USER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071005</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557888-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-062692</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DANDY-WALKER SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557889-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557890-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557891-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>3000418C00,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160MCG/4.5MCG UNKNWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557892-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE18916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557893-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-003078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557894-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-US-2006-000218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051226</drugenddate>
        <drugtreatmentduration>243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557895-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7141045</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557896-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7000029</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANTIDAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557897-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7141017</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>632</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557898-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7140815</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557899-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20120712357</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557900-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>RECEIVED 5 DOSES REMICADE IN 2011</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557901-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20120713805</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557902-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120714587</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IRMA65002</drugbatchnumb>
        <drugdosagetext>3RD INDUCTION DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IRMA65002</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557903-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557904-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>OVER A PERIOD OF 13 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557905-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugdosagetext>OVER A PERIOD OF 7 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557906-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557907-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710997</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557908-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>FOR 18 MONTHS</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557911-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7111743</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTI INFLAMMATORY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU001410</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557912-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-US-EMD SERONO, INC.-7143433</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROANGIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557913-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7150649</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557914-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7022772</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>Y15A5285,AU002661</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557915-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7111062</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPILEPTIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557916-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15962160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SAXAGLIPTIN</medicinalproduct>
        <drugauthorizationnumb>22350</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: PLACEBO</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557917-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16798845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557918-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-005417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1B</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1B</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1B</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUBAIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXIMET</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 U, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1B</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBITAL ACETAMINOPHEN AND CAFFEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIGAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA-1B</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090612</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557919-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16796146</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>15APR2001-10MAY2005 10MAY2005-24MAR2008 04MAR2008-27FEB2012</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>10MAY2005-24MAR2008 04MAR2008-27FEB2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>04MAR2008-27FEB2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557920-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-12989398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DERMOPLAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>1ST COURSE DOCETAXEL 30-MAR-2005. WEEKS 2-7 DOCETAXEL WEEKLY 15 MG/M2. TOTAL DOSE:26.1MG</drugdosagetext>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>1ST COURSE:30-MAR-2005. WEEK 1 LOADING DOSE400 MG/M2. WEEKS 2-7, WEEKLY 250 MG/M2. TOTALDOSE:435MG</drugdosagetext>
        <drugindication>HEAD AND NECK CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557921-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16714313</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEVIT-D</medicinalproduct>
        <drugdosagetext>1 DF: 2 CAPSULES</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOMYCIN SULFATE TAB</medicinalproduct>
        <drugdosagetext>INJ</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONODUR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557922-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16798795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>1DF:1 VIAL  LAST INF WAS 6-7 WEEKS AGO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557923-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE32264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>3 TABLET IN THE MORNING AND 3 TABLET AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>3 TABLET IN THE MORNING AND 3 TABLET AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557924-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ASTRAZENECA-2012SE15539</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21864</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>400/12, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>400/12, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557925-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557927-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16582BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557928-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CN-01638CN</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557929-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14319BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>1555200 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557930-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>111</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557931-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US005856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557932-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012SE011018</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>DOUBLE BINDED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557933-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>150 UG, PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBRE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557934-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AT058255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557937-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003272</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557938-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557939-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012LU062037</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557940-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US008807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0009</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>1 G, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>0.125 MG, TID</drugdosagetext>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557941-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065611</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>80 MG, ONE TABLET PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
        <drugdosagetext>2.5 MG, ONE TABLET PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557942-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012KW065086</companynumb>
    <primarysource>
      <reportercountry>KUWAIT</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557943-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011BR38587</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557944-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065657</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTOR GAL</medicinalproduct>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANAZOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>1.3 ML, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557945-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA099085</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557946-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>600 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557947-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004198</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557948-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557949-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-JNJFOC-20120714583</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557950-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPRELAN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557951-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120708239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS HAEMATOPHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>10 (UNITS UNSPECIFIED)/KG ADMINSITERED ON 26-JUN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>10 (UNITS UNSPECIFIED)/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557952-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IS-JNJFOC-20120705131</companynumb>
    <primarysource>
      <reportercountry>ICELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557953-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120713057</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557954-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557955-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>5 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557956-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>MM860</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557957-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711016</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557958-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557959-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>TAKE AN EXTRA DOSE SOMETIMES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>TAKE AN EXTRA DOSE SOMETIMES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>TAKE AN EXTRA DOSE SOMETIMES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557960-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557961-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201202005108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                                 /SCH/</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPICAL                            /00806601/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A875282D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120131</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, OTHER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A875282D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON                                /GFR/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557962-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207002637</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557963-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201107002037</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840123C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A939725G</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877625C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557964-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ELI_LILLY_AND_COMPANY-CO201207005340</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A939728C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557965-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201207007015</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557966-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201202005281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A897246J</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840122F</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877625C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557967-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206007068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.354</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A883534G</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTH</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557968-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207006989</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557969-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207007117</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557970-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206004787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A862855D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557971-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201112005386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A875282D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557972-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ELI_LILLY_AND_COMPANY-FI201207007162</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557973-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201108000316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A862854C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A862854C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A897246J</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAGLIP</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A872709C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A842600F</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D NOS</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557974-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557975-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1205USA02822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557976-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-348763USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HUMAN CHORIONIC GONADOTROPIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY AFTER POST COITAL CONTRACEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557977-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557978-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557979-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-001521</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOBUN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557980-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076102</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557981-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-349372USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557982-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350056USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.756</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557984-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS CEREBRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557985-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557986-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557987-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987491A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugbatchnumb>13411</drugbatchnumb>
        <drugauthorizationnumb>021887</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>WEIGHT LOSS DIET</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557988-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987493A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM CQ</medicinalproduct>
        <drugbatchnumb>1202370</drugbatchnumb>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557989-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1210216US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>2 GTT, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
        <drugbatchnumb>75255</drugbatchnumb>
        <drugauthorizationnumb>021770</drugauthorizationnumb>
        <drugdosagetext>2 GTT, UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557990-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19971110</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-009507513-97105570</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557991-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1106USA00373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR LENS IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060303</drugenddate>
        <drugtreatmentduration>997</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557992-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557993-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557994-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPRELSA</medicinalproduct>
        <drugauthorizationnumb>022405</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>80/4.5 MCG UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8557999-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16682304</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN GERM CELL TERATOMA BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDEP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558000-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20120611760</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>26.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558001-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120702626</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558002-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20110509717</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMEAR CERVIX ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLPOSCOPY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICETEL</medicinalproduct>
        <drugdosagetext>AS AND WHEN REQUIRED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA82103;IRMA64101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA82103;IRMA64101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA82103;IRMA64101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>ORMKA82103;IRMA64101</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558003-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120707576</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JEJUNAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>10-APR (ASSUMABLY 2012)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>22-MAY (ASSUMABLY 2012)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>24-APR (ASSUMABLY 2012)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120602731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>CBM10013P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>ONCE EVERY TUESDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>CBM10013P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>EE-BRISTOL-MYERS SQUIBB COMPANY-16828865</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>THERAPY ON 12JAN12</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558006-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-21880-12072535</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558007-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558008-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558009-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558010-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558011-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-12072616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>1000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080521</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558013-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080911</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1088424</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>MALIGNANT LYMPHOID NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558016-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041518NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558017-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-053917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, QOD (1 PILL EVERY OTHER DAY)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558018-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-JNJFOC-20120711875</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLEOMYCIN SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHEMORADIATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HODGKIN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558019-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-1094996</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>12817403</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120127</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558020-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558021-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>5.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558022-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugdosagetext>ONE INHAILATION DAILY IN MORNING</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>NASAL POLYPS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PATANOL</medicinalproduct>
        <drugindication>EYE IRRITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-011095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VERTEX PHARMACEUTICALS INC.-000000000000000684</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO (TELAPREVIR)</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: INJECTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugbatchnumb>V111996</drugbatchnumb>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558027-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACROCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>443</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012151748</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugauthorizationnumb>011153</drugauthorizationnumb>
        <drugdosagetext>125 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558030-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012171555</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALODONT</medicinalproduct>
        <drugdosagetext>2 BATHES/DAY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG, EVERY 4 HRS (6X/DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROSULF</medicinalproduct>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>2 BATHES, DAILY</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIXICAL</medicinalproduct>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CALCIUM DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>7 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE TEST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558032-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012173236</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIMB OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558033-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012158697</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION SUICIDAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10MG/40MG,1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, AS NEEDED AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558034-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012176321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.095</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>150 UG, 5 TIMES A WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>750 MG, LONG ACTING, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>175 UG, 2X/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558035-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-DE-WYE-H18213910</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>750 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101007</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558037-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAMIDINE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE291537</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUPERINFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077C,S0077C,S0078A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077C,S0077C,S0078A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (NOT SPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS (NOT SPECIFIED)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077C,S0077C,S0078A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077C,S0077C,S0078A</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0077C,S0077C,S0078A</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXEZE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558040-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558042-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011080</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM IODIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BASEDOW'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROTYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-EISAI INC-E7389-02773-SPO-IT</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558044-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959712-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>100/25 MILLIGRAM, DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2 TABLETS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558045-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0953204-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0961584-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEKRISTOL</medicinalproduct>
        <drugdosagetext>20000 IU EVERY FOUR WEEKS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugdosagetext>10 MCG PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0958089-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INTESTINAL FISTULA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558048-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0962088-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEKRISTOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DREISAVIT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021606</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALITHROM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558050-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1090967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>B-LYMPHOCYTE ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE TIMING UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558051-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOLVULUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558054-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080414</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A952353A</drugbatchnumb>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558056-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201110004408</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877625C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840123C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugbatchnumb>A949784A</drugbatchnumb>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558058-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201207008986</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558059-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007460</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558060-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007425</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558061-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201207007259</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558062-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007435</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558064-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007483</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201207005929</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558066-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT201207009264</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558067-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007467</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROSCOPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558068-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201207007812</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DESTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A972302C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558069-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2012SE27198</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINERGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>HALF TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558070-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201205007696</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A897247J</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558071-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558072-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1103USA00954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM GLUCONATE TAB</medicinalproduct>
        <drugdosagetext>550 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM ZINC</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE (IMITREX)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
        <drugtreatmentduration>757</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558073-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BMSGILMSD-2012-0058843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558074-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-005993</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558075-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558076-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558077-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558078-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PR-BAYER-2012-077136</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugbatchnumb>14271A</drugbatchnumb>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>7.5 UNK</drugdosagetext>
        <drugindication>SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558079-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BAYER-2012-076994</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>250 ?G, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558080-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-044785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION (NOS)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>8 U, WITH EACH MEAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>30 U, BID AT BEDTIME</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 2 TABLET EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, Q. 5 MINUTES</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>2 MG, 1 TO 2 TABLETS BID, R.P.N.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG, QD AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATIC CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD GLUCOSE FLUCTUATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, QID P.R.N.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>1 MG/KG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>100 MG, REPORTEDLY: Q DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIFICIAL TEARS [ARTIFICIAL TEARS]</medicinalproduct>
        <drugdosagetext>1 DRIP ONE EACH P.R.N.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD CREATININE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558081-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558082-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-2012SP036942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558083-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BINGE EATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>BETWEEN 5 TO 20 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558084-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558085-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-2012SP036710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BINGE EATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>DOSES BETWEEN 5 TO 20MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VERTEX PHARMACEUTICALS INC.-000000000000000961</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PORTAL VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558088-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-06140BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.32</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16568BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558090-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-07112BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL BOWING OF LONG BONES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULTRASOUND ANTENATAL SCREEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW BIRTH WEIGHT BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISOMY 21</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE DURING PREGNANCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16579BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558092-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17033BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>(TABLET) STRENGTH: 37.5 MG; DAILY DOSE: 37.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558093-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-62653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNCTIONAL GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP012P0101/IP014P0101/IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558094-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-59734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>KH028H0101/KH039H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>5 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2011-54953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP084P0101/IP018P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558096-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP038P0104</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2011-58808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP084P0101/BP091P0103/IP014P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>03590A, MA000HD</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558102-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120712823</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558103-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120517327</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACCIDENTAL EXPOSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558104-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021689</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558106-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2012SE30172</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>16/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>16/5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP035889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORGASULINE RAPIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558109-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPPERTONE SPORT DRY LOTION SPF-30</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558110-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE27779</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31312</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>20838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>20 MG PER DAY ALTERNATELY WITH 20 MG 1.25 DF PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0962275-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957510-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>102322E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558114-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933892-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.664</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL MUCOSAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL BACTERIAL OVERGROWTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFAECATION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISCERAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERADRENALISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>COMPLETELY OFF AND WILL TRY TO KEEP OFF TAPER DOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugdosagetext>1 SCOOP TWICE DAILY(1GRAMDAILY)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANUCORT-HC</medicinalproduct>
        <drugdosagetext>AT NIGHT IN PLACE OF PROTOCORT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugdosagetext>1 SCOOP TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTOCORT</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ABBOTT-12P-143-0960824-00</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20MG PER WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>120MG OR 160MG IMI</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURICOS</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558116-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0938285-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>150 MG IN AM, 100MG IN PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>10/500</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1-1/2 TABLETS AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>PATCH ONCE DAILY</drugdosagetext>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SLIDING SCALE QID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>GASTROENTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugdosagetext>1 GTT DAILY</drugdosagetext>
        <drugindication>EYE IRRITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959961-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HELLP SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558118-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-ABBOTT-12P-251-0961602-00</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>1M0047</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>1M0047</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>1M0047</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0961605-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT GAIN POOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.35</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>PULMONARY OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558121-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-TEVA-349999ISR</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TUBULAR ACIDOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076317</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2012131959</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugindication>DIABETIC FOOT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558123-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011100334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
        <drugtreatmentduration>395</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
        <drugauthorizationnumb>21437</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110426</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
        <drugtreatmentduration>818</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110427</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY FOR 4 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY FOR 3 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558125-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRICHORRHEXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558126-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010035776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING MONTH PACK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG TABLET, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558127-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE38526</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>972</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugbatchnumb>JG420,,,</drugbatchnumb>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>020578</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558129-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>1IRJ604</drugbatchnumb>
        <drugdosagetext>120 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558130-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>40 UNK, UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558132-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE24175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558133-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE40958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR RETROBULBAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558135-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19960426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-96042447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-2933</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558136-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF MALIGNANT DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558137-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN007451</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100MCG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558138-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE38866</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugauthorizationnumb>021344</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558139-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGE-RELATED MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040901</drugenddate>
        <drugtreatmentduration>1098</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>50000 IU, BIW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>2287</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040201</drugenddate>
        <drugtreatmentduration>1189</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071026</drugenddate>
        <drugtreatmentduration>2189</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, TIW</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558140-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558141-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558142-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20120800387</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558143-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558144-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE31393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METAMORPHOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugdosagetext>1 TABLET, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558145-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558149-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012173943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>THRICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>THRICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>THRICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>THRICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>THRICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>THRICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>THRICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO SUBJECT DRUG</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558150-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAYER HEADACHE RELIEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558151-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLIMARA PRO</medicinalproduct>
        <drugbatchnumb>110382</drugbatchnumb>
        <drugauthorizationnumb>021258</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558153-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041571NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558154-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-2012SP033268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>225 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558155-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-048654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROTIGOTINE</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558156-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE37050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558157-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE40843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUSIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558158-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012011773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORYX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558160-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351424USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>3380528</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABORTION INDUCED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558161-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0960407-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558162-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-12P-150-0951084-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PRE FILLED PEN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PRE FILLED SYRINGE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558163-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0950070-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>100MG OD</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558164-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0949853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>140762E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558165-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0960769-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558168-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558169-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558170-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558171-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558172-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-007694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETERAL STENT INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558173-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-006050</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558174-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008495</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REZALTAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558175-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP031103</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558176-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NAPPMUNDI-MAG-2012-0002212</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>10 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558177-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE07593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>GENERIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558178-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>8 MG, 1 TABLET THREE TIMES A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5MG/325MG, 1 TABLET BY MOUTH ONE TIME A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>37.5/325 MG, 1 TO 2 TABLET BY MOUTH EVERY 8 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558179-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE42922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558180-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16808156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>LAST INF ON 06APR12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558181-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NAPPMUNDI-MAG-2012-0002232</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>5 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>1500 MCG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>5 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugdosagetext>15 MCG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>10 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL COMPRESSION FRACTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>16 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>10 G, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>20 G, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOHRUS L</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558182-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16815730</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>LAST DOSE ON:11-NOV-2011</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558183-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16803355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>1 DF = PUFF, 250/50 UNITS NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugdosagetext>1 DF = CAPSULE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>NEBS PRN, 0.8390 UNITS NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF = 0.088 UNITS NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>1 DF = 5/325 UNITS NOS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558187-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012155764</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDULLOBLASTOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN RDNA</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090625</drugenddate>
        <drugtreatmentduration>1229</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558188-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012175856</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>165</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558189-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2012-073764</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
        <drugtreatmentduration>326</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG/D (2-0-1)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>800 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558190-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NAPPMUNDI-GBR-2012-0011106</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>30 MG, ODD DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558191-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>FMXL87</drugbatchnumb>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558192-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP030653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558193-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP030310</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugbatchnumb>100143</drugbatchnumb>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558195-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558196-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERPECIN L STICK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EX-LAX CHOCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SOD DR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER POIGRIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL MIGRAINE LIQUI-GELS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RA TRIPLE ANTIBIOTIC ONTMENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2009SP029107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>225 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-349869USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-351340USA</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>22249</drugauthorizationnumb>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>CYCLIC</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558200-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16532BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558206-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>CUTTING PILLS IN HALF, EVERY OTHER MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558208-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1108USA02806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVARIAN ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>702</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
        <drugtreatmentduration>1159</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
        <drugtreatmentduration>1525</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHETAMINES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351318USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAUSCH-BL-2012-000158</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CROMOLUX 2% EYE DROPS</medicinalproduct>
        <drugauthorizationnumb>74443</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041921NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.41</patientweight>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU003S8</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558223-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558224-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-NAPPMUNDI-MAG-2012-0002240</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>90 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPEN                              /00613801/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558227-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012GB011191</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>75539</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>1.5 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>2.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
        <drugdosagetext>40 UG, BIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BHQ880</medicinalproduct>
        <drugdosagetext>780 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558228-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012PL064627</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE SEPARATION OF PLACENTA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB064530</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE DELIVERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>078409</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>078409</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US064469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>075968</drugauthorizationnumb>
        <drugdosagetext>600-800 MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558231-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT064857</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>7.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVATED COAL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>77713</drugauthorizationnumb>
        <drugdosagetext>6000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558232-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CH065323</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF PROPRIOCEPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS RHYTHM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077040</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558233-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20120712661</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>AS NEEDED AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HALLUCINATION, AUDITORY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558234-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>1122MG IN NORMAL SALINE 2000 ML OVER 24 HOURS DAILY FOR 3 DAYS ON DAYS 2-4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>1EA</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>AS NEEDED 10 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDES-DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>AS NEEDED (ONCE IN EVERY 12 HOUR)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>AS NEEDED 31 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>94 MG OVER 15 MINUTES FOR 1 DOSE ON DAY 5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>PUSH OVER 3-5 SECONDS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>ON DAYS 2-5 AND DAYS 12-15</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAY 5 AND DAY 12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>MONDAY THROUGH FRIDAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
        <drugdosagetext>03 DAYS</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOMATOLOGICALS, MOUTH PREPARATIONS</medicinalproduct>
        <drugdosagetext>SWISH AND SPLIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>CHRONIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>AS NEEDED 01 DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558235-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120607999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNIOTIC FLUID VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugauthorizationnumb>022187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558236-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120708895</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>17694</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNE-B6 /00869101/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC GLUCONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>INITIATED FOR 2 YEARS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558237-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558238-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120614761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558239-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558240-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120509817</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558241-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB042610</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>078528</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugdosagetext>150 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558242-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB064951</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>018740</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugdosagetext>1.5 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugauthorizationnumb>18740</drugauthorizationnumb>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1.2 G, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558243-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012ES064968</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISULFIRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPROSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>076120</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558244-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065922</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>075985</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558245-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB058699</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076189</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558246-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065391</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>077514</drugauthorizationnumb>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558247-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB060721</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>80336</drugauthorizationnumb>
        <drugindication>B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558248-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2011TW04462</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110324</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROWN MIXTURE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK (REDUCED DOSAGE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110903</drugenddate>
        <drugtreatmentduration>163</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110116</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110102</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOBAY</medicinalproduct>
        <drugdosagetext>5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOKEY EMC</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>6.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110906</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110130</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>078227</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558249-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY BLADDER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugauthorizationnumb>074925</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558250-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB055502</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>077514</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558251-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB058316</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugbatchnumb>2070312</drugbatchnumb>
        <drugauthorizationnumb>077575</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558252-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558253-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROINTESTINAL PREPARATIONS (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558254-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558255-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558256-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DZ-ASTRAZENECA-2012SE52638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAPID EYE MOVEMENTS SLEEP ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALOXONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETIME HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDORXAZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558257-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1108USA01227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DEPOSIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS SEASONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST LAMINECTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70  MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558258-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-2012SP029726</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>70 MG/M2, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL SODIUM</medicinalproduct>
        <drugdosagetext>1300 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>70 MG/M2, QD</drugdosagetext>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110614</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>70 MG/M2, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110602</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>400 MG, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558259-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351339USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558260-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120606782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugdosagetext>POST LEAD-IN PERIOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugauthorizationnumb>20634</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558261-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558262-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53060</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558263-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2009UW03332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558265-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110104</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042004NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.295</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU003P5</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558266-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP029669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugdosagetext>2-4 PUFFS / TWICE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558267-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1205USA05003</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>DIVIDED DOSE FREQUENCY UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>DIVIDED DOSE FREQUENCY U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>DIVIDED DOSE FREQUENCY U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558268-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1110USA02425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIOSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugbatchnumb>X4973</drugbatchnumb>
        <drugdosagetext>70MG/2800</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081211</drugenddate>
        <drugtreatmentduration>591</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>2348</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1006</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70/2800</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070401</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558269-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VIROPHARMA INCORPORATED-20120725CINRY3194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINRYZE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>HEREDITARY ANGIOEDEMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558270-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558271-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558272-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558273-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E2090-02221-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110704</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558274-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090633</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>WKM61</drugbatchnumb>
        <drugauthorizationnumb>022272</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558278-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20120713974</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558279-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120516979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558280-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120715280</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20120610384</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORGESTIMATE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>019653</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120513076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>100 UNIT/ML, BEFORE MEALS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugbatchnumb>2AG540</drugbatchnumb>
        <drugauthorizationnumb>020193</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558284-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558285-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558286-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207007387</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558287-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEART RATE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558288-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207007021</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, EACH MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 U, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558290-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206005725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558291-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201103008504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A801175E</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>125 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER B COMPLEX</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A845027K</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METENIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 U, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO BI-FLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>375 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558292-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206005682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558293-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK, 3/W</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558294-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947300-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSILATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugdosagetext>1 CAPSULE AM, 2 CAPSULE PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558295-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873679-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STILLBIRTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022417</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 TAB/CAP DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558296-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950624-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LO-OVRAL BIRTH CONTROL</medicinalproduct>
        <drugdosagetext>PILL EVERY DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8 PILLS EVERY WEEK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>151992E</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558297-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-12P-066-0959783-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROIDITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110609</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558298-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950035-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558299-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-2012SP029208</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URETERIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE/LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugauthorizationnumb>019625</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558300-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2009SE16256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558301-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE EXTENDED RELEASE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558302-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2008UW16328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>5/325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558304-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042005NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU0064H</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558305-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-009507513-2012SP027896</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOMEGESTROL ACETATE/ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MICROGRAM, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558306-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1201USA00751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>D (2800)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
        <drugtreatmentduration>1198</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
        <drugtreatmentduration>1776</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558307-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP028312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugdosagetext>220 MICROGRAM, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558308-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA04488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, HS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558309-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558310-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558312-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14926BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.01</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 MCG</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugindication>HEART RATE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558313-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16521NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558314-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16577BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558315-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16571BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HEART RATE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558316-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558317-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558318-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558320-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-1205USA04893</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATYPICAL FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558321-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP027220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>1IRC605</drugbatchnumb>
        <drugdosagetext>150 ?G, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558322-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugdosagetext>1 SPRAY DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>1 SPRAY DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>20746</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558323-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558324-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558328-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558329-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EP3</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, UNK</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076713</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHILLIPS' MILK OF MAGNESIA LIQUID ORIGINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-BAYER-2012-074161</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.213</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITE [VITAMINS NOS]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHILLIPS' COLON HEALTH</medicinalproduct>
        <drugbatchnumb>2A05A</drugbatchnumb>
        <drugdosagetext>ONCE DAILY WITH FOOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558333-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE45163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558335-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>300 MG EVERY FOUR PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>300 MG EVERY FOUR PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>300 MG EVERY FOUR PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558336-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011032</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100 UNK, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP031765</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>1 MICROG/BODY, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>5 MG/BODY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugauthorizationnumb>020497</drugauthorizationnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER STAGE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG/BODY, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>200 MG/BODY, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2 MG/BODY, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR012584</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGASMIC SENSATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEMEN VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANDROGENETIC ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558339-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MSD-2011SP036291</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>162.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POSACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>022003</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558340-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2010SP056507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MK-4031</medicinalproduct>
        <drugdosagetext>80 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-061981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMPAT</medicinalproduct>
        <drugauthorizationnumb>022253</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558342-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952360-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL HD</medicinalproduct>
        <drugdosagetext>DR</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558343-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0961552-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558344-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-12P-020-0958623-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558345-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ABBOTT-12P-129-0960847-00</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558346-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESCUE INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558348-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2009UW06552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558349-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2009UW15077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558350-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351363USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558351-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008011</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558352-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ELI_LILLY_AND_COMPANY-NL201202001417</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558353-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>50 U, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>55 U, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558354-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007988</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558355-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007952</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ELI_LILLY_AND_COMPANY-FI201207002901</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXIKLORIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTACID THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558357-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207007538</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558358-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207007586</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558359-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201207007974</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558360-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201202007936</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSEUDARTHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXIAGO</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558361-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA201207006916</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRACTIN                          /00006201/</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEZ                               /00661201/</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENAP</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPOGEN</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURICOS</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>18 IU, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTROMET</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIFEROL</medicinalproduct>
        <drugdosagetext>5000 IU, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A937085D</drugbatchnumb>
        <drugauthorizationnumb>20563</drugauthorizationnumb>
        <drugdosagetext>6 U, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARLOC</medicinalproduct>
        <drugdosagetext>6.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURESIS</medicinalproduct>
        <drugdosagetext>.5 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558362-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207007865</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558365-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DR. SCHOLL'S INGROWN TOENAIL PAIN RELIEVER</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-0904USA01370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO POSITIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSCILLOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARACHNOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIRIFORMIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDINOUS CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70MG/2800</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070625</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060201</drugenddate>
        <drugtreatmentduration>701</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070409</drugenddate>
        <drugtreatmentduration>298</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558368-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558369-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE14767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558370-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAXTER-2012BAX010473</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TISSEEL VH</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012786</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMPT.X_GLUTAMINE 480.00 G_POWDER FOR SOLUTION_BOTTLE, GLASS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX011312</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 1.5% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2012BAX012796</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 4.25%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558377-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558378-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMPT.X_GLUTAMINE 480.00 G_POWDER FOR SOLUTION_BOTTLE, GLASS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558379-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558380-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558381-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-BAXTER-2012BAX012806</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 4.25%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558382-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558383-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558384-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX009330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558385-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX006739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>C866368A,C865048,C861344</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>C867374,C863266,C860080</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558386-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-BAXTER-2012BAX000006</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS B SURFACE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B CORE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B ANTIGEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIOVIG</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugdosagetext>20 G/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KIOVIG</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugdosagetext>20 G/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558387-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX007599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558388-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558389-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE00535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON- INTRAVENOUS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558390-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE61480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558391-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558395-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-2012SP000978</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111223</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>4.96 MG, QD</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugauthorizationnumb>22277</drugauthorizationnumb>
        <drugdosagetext>75 MG/M2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>75 MCG, QD</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>75 MCG, QD</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>75 MCG, QD</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111228</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>4.96 MG, QD</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>4.96 MG, QD</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120112</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558396-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE15653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558397-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558398-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE11792</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558399-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558400-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE12659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-JHP PHARMACEUTICALS, LLC-JHP201200389</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PITRESSIN</medicinalproduct>
        <drugdosagetext>0.0005 TO 0.003 UNITS/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SHOCK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JHP PHARMACEUTICALS, LLC-JHP201200392</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DANTRIUM</medicinalproduct>
        <drugauthorizationnumb>017443</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19970331</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-97040026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970331</drugenddate>
        <drugtreatmentduration>212</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9039</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558406-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MSD-2012SP017800</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0909187-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>GASTRIC MUCOSAL LESION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYCARBOPHIL CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111222</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ABBOTT-12P-127-0959896-00</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDUCTIVE DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>14267XH03</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942085-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>10/25 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/20 MG</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558410-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959288-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>50 MG DURING THE DAY AND 400 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558412-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE31798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAEDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558413-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE17118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558414-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076848</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBPHRONE</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>4 DF, UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>20204</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558415-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558416-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558417-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558418-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>8 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558419-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558420-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-071180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.887</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>NAA06R7</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558423-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>6 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558424-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP019527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJURY ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558425-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP019543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugbatchnumb>940738</drugbatchnumb>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QM</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558426-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558428-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065392</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugauthorizationnumb>077515</drugauthorizationnumb>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558430-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065752</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>3820</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>16 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 G DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>1264</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>074376</drugauthorizationnumb>
        <drugdosagetext>1 DF,</drugdosagetext>
        <drugadministrationroute>049</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>898</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>898</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558431-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP061947</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS LUPUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>065017</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUPUS NEPHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB000641</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>079206</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
        <drugtreatmentduration>1975</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB000641</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
        <drugtreatmentduration>1975</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558435-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003819</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>077766</drugauthorizationnumb>
        <drugdosagetext>40 MIXED TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>40 DF, (MIXED TABLET) WHICH INCLUDED CLOZARIL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>793</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558436-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POSACONAZOLE</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugauthorizationnumb>091201</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558437-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012PL064142</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BROMOCRIPTINE MESYLATE</medicinalproduct>
        <drugauthorizationnumb>074631</drugauthorizationnumb>
        <drugindication>PROLACTINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558438-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP059583</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BEHCET'S SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558439-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB065747</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>74376</drugauthorizationnumb>
        <drugdosagetext>50 MG, 14 DF (14 ? 50MG DICLOFENAC TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEFOPAM</medicinalproduct>
        <drugdosagetext>30 MG, 60 DF (60 ? 30MG TABLETS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558440-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP50217</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>15 U, EVERY 3 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110511</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>080339</drugauthorizationnumb>
        <drugdosagetext>8 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>14 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>10 DF, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>4 U, EVERY TWO WEEKS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugdosagetext>15 U, EVERY 3 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110605</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS, CONCENTRATED</medicinalproduct>
        <drugdosagetext>4 U, EVERY THREE WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110831</drugenddate>
        <drugtreatmentduration>350</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOGLIBOSE</medicinalproduct>
        <drugdosagetext>0.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTOL-XE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110403</drugenddate>
        <drugtreatmentduration>565</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugdosagetext>625 MG, ON ALTERNATE DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110502</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugdosagetext>625 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110518</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>080339</drugauthorizationnumb>
        <drugdosagetext>7 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100202</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>080339</drugauthorizationnumb>
        <drugdosagetext>6 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100421</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>080339</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>12 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>10 DF, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugauthorizationnumb>080339</drugauthorizationnumb>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558441-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-BIOMARINP-002752</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AEROMONA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAGLAZYME</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS VI</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558442-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BR-00862BR</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558443-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE40434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558444-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE48576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558445-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558447-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP023098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558448-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP024564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558449-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0056643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558450-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558452-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE63737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558453-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-350125GER</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PIERRE ROBIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MITOXANTRONE</medicinalproduct>
        <drugauthorizationnumb>077356</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558454-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558455-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE78902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558456-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE39865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558457-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011106</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558458-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP025434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558459-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011066</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558460-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP010635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPHOSPHOLIPID ANTIBODIES POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558462-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN007454</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558463-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558464-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558465-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558466-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2012BAX012897</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 4.25%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CUBIST-2012S1000449</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558468-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-1205USA05144</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATYPICAL FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558469-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DANDRUFF</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558470-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP026072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugbatchnumb>GMD011</drugbatchnumb>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558471-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QPM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558472-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558473-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558474-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE06159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558475-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558477-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558478-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BAYER-2012-068157</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS MICROSCOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>100MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558479-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP026393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugbatchnumb>1JS408</drugbatchnumb>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558480-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP040934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY PNEUMATOCELE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080921</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558481-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ABBOTT-12P-036-0962839-00</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558482-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960196-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>081492E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558483-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0962250-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>EVERY OTHER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558484-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948698-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.848</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>120822E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558485-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE15403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONNATAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558486-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558487-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558488-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-INCYTE CORPORATION-2012IN001252</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOFIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCB018424 (RUXOLITINIB)</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCB018424 (RUXOLITINIB)</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>NOT SPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558489-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-INCYTE CORPORATION-2012IN001291</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INC424</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558490-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE18604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIR-81 TBEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111222</drugenddate>
        <drugtreatmentduration>806</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558491-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE33706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558492-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558493-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201207007015</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558494-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-ELI_LILLY_AND_COMPANY-HR201206002208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2/M</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>405 MG, MONTHLY (1/M)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558495-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201110004083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALPINGO-OOPHORECTOMY BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNCTIONAL GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D.H.E. 45</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A862855E</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>2 MG, EACH EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, EACH EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558496-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201109006296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840123C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A883536C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A875282D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840122F</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558497-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US008807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>0.125 MG, TID</drugdosagetext>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>300 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0009</drugbatchnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>1 G, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558498-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP026608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558499-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-1205USA05146</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATYPICAL FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPIONATE DE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558501-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120521</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP027204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558502-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558503-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558504-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558505-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE21924</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558506-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20040816</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120606438</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PPI</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>020325</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONSTEROIDAL ANTIINFLAMMATORY DRUGS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>020325</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558507-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20000328</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120606437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugbatchnumb>J6671</drugbatchnumb>
        <drugauthorizationnumb>20325</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>020325</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCUROCHROME-220-HWD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISMUTH SUBSALICYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID RPD</medicinalproduct>
        <drugbatchnumb>J6671</drugbatchnumb>
        <drugauthorizationnumb>020325</drugauthorizationnumb>
        <drugdosagetext>ORALLY DISINTIGRATING TABLET ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>020325</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558508-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>KH039H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>14 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558509-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558510-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558511-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558512-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558513-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558514-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16573BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>125 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>6.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>20 MEQ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>900 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558515-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA012091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558516-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558517-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558518-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE42642</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558519-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350268ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDACTYLY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>076420</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558520-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558521-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE47335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558522-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558523-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL438174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>143.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>12.5 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D                /01483701/</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018611</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
        <drugtreatmentduration>1008</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 IU, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>42 IU, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG, Q5MIN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>7.5 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>25 IU, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558524-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRACT2012031506</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>492 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINATE CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>170 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OESOPHAGEAL ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558525-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558526-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-1205USA05147</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATYPICAL FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558527-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE38288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>3000422C00,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5, 2 PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX (PRN)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558528-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558529-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558530-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0928028-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CURCUMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>UNK.</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558531-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960228-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAXIMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558532-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0937841-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558533-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120223</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-50794-12053033</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558534-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX010177</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUDDEN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558535-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558536-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BAXTER-2012BAX008727</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARTISS</medicinalproduct>
        <drugbatchnumb>VND6L008</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558537-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185061</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558538-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012183712</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558539-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185367</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558540-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090809</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185705</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558541-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE47720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558542-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMYOTROPHIC LATERAL SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558543-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558544-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350731USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558545-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-TEVA-351008ISR</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>ARG3ALC</drugbatchnumb>
        <drugauthorizationnumb>074656</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>.4 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEP-9722</medicinalproduct>
        <drugbatchnumb>11000255</drugbatchnumb>
        <drugdosagetext>800 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
        <drugbatchnumb>GM210049Z,GM110009U</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHYLMORPHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOFENAMATE GEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugdosagetext>1000 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugdosagetext>2 ;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558546-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351474USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558547-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-2012-067136</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>1273</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558548-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-1205USA05145</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATYPICAL FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558549-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>HMLX58</drugbatchnumb>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558550-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-50794-12073241</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLAST CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARENOXACIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120213</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558551-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-350122ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugauthorizationnumb>074578</drugauthorizationnumb>
        <drugdosagetext>3200 MILLIGRAM; 3200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIOPAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCO CARBIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTEGEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugdosagetext>25UG SALMETEROL/250UG FLUTICASONE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558552-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMOR THYROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558553-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558554-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53037</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558555-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558556-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-UCBSA-062628</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugbatchnumb>57215</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558557-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558558-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL OBSERVATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558559-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558560-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350290ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>450 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076119</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558561-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000029239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALIRESP</medicinalproduct>
        <drugauthorizationnumb>022522</drugauthorizationnumb>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugdosagetext>220 MCG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558562-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-21880-12073217</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558563-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE47786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558564-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558566-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012180129</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>ONE TABLET ONCE DAILY</drugdosagetext>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMALGIN CARDIO</medicinalproduct>
        <drugdosagetext>ONE TABLET ONCE DAILY</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>1 TABLET ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558567-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012165126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEREDITARY ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CINRYZE</medicinalproduct>
        <drugdosagetext>1000 UNIT, 3 IN 1 WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>3-4 TABLETS A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558568-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012182492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYP COLORECTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19740101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.4 MG, DAILY, 7INJECTIONS/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558569-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012184207</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558570-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, 2X/DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558571-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012177900</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>60 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CICLOSPORIN</medicinalproduct>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558572-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012177920</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugauthorizationnumb>21845</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558573-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012168396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558574-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12071560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>2.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558575-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-BAYER-2012-076914</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugauthorizationnumb>018230</drugauthorizationnumb>
        <drugdosagetext>1 %, QD</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558576-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-UCBSA-062652</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>896</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCARB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-MSD-1208CAN000371</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>022277</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOFT TISSUE NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558578-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558579-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYSTANE ULTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABIRATERONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALEPLON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558581-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE39808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>80/4.5, 2 PUFFS TWICE A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>80/4.5 MCG, ONE PUFF TWICE DAILY/ I INHALATION BID AS NEEDED AFTER EXERCISE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558583-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201102992</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEXABRIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018905</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>ARTHROGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugdosagetext>5 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>ARTHROGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>12 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>014</drugadministrationroute>
        <drugindication>ARTHROGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558584-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP059312</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>45 MG/ MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG/ MONTH</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG/ MONTH</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558585-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2011056208</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558586-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ABBOTT-12P-114-0956297-00</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2X40MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-HYPERTENSION MEDICATION (NOS)</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558587-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959679-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558588-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2012BAX012520</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICNU</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEPESID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558589-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16789505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT SUBQ INJECTION 125MG/ML</medicinalproduct>
        <drugbatchnumb>2A71599</drugbatchnumb>
        <drugdosagetext>PRES. #: 21-3589320.LAST INJECTION WAS ON 14JUL2012</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558590-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558591-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE47935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERTUSSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>3000433C0,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PERTUSSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>3000433C0,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>1 PUFF BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558592-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558593-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-1208CAN000074</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558594-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-FRI-1000029225</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILYFTER</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>021323</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>021323</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558595-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-050693</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DOSE :25</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2 X 2.5 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15,0 (UNSPECIFIED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558596-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558597-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN CONSUMPTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGY TO CHEMICALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558598-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE47953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>127.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 TWO PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 TWO PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012151741</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
        <drugdosagetext>1MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>37.5MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558601-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558602-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-057379</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTATIC BRONCHIAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE AS CORTISONE PULSE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>NO OF DOSES-2</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-FRI-1000037143</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021046</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-FRI-1000037366</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MECHANICAL ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558605-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOMARINP-002755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KUVAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022181</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHENYLKETONURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ROCHE-1083316</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERTUZUMAB</medicinalproduct>
        <drugbatchnumb>H0006</drugbatchnumb>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 14/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 28/JUN/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>B1592</drugbatchnumb>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 14/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 14/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE318744</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>300 MG, Q4W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1084771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASPARGASE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTEPLASE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SUPERIOR SAGITTAL SINUS THROMBOSIS</drugindication>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1084769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR SAGITTAL SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTEPLASE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-CID000000002060751</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOSS (GERMANY)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITREPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTYRAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDINE</medicinalproduct>
        <drugdosagetext>50/4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558611-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558612-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1006027</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558615-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558616-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-650882</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSEFORM: PERORAL AGENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>DOSEFORM: PERORAL AGENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>DRUG: ALFAROL CAPSULES.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAKAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS BONALON 5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugdosagetext>DRUG: FLIVAS OD.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS HARNAL D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>DOSE FORM: PERORAL AGENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>DOSEFORM: PERORAL AGENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>DOSEFORM: PERORAL AGENT.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLATE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558617-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1062045</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE (CANADA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558618-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1084775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL DECOMPENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENTRICLE DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTEPLASE</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>SUPERIOR SAGITTAL SINUS THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SUPERIOR SAGITTAL SINUS THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091228</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-12072934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558621-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>DAILY BASIS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558622-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1061433</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTEPLASE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EMBOLIC STROKE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDARAVONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDARAVONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUCROSE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111231</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558623-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558624-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUSTER HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>020768</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558625-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE51614</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HCL</medicinalproduct>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020533</drugauthorizationnumb>
        <drugadministrationroute>053</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558626-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041921NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.41</patientweight>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU003S8</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558627-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1075501</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558628-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558629-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESTROGEN REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558630-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094642</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugdosagetext>LAST DOSE: 15 JUN 2012</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558631-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558632-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1054429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558633-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110217</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558634-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072972</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>2.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>25 MICROGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE51568</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugdosagetext>WITH ADREANALINE</drugdosagetext>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugdosagetext>1-2 MG</drugdosagetext>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020533</drugauthorizationnumb>
        <drugadministrationroute>053</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE51609</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020533</drugauthorizationnumb>
        <drugadministrationroute>053</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugdosagetext>1-2 MG</drugdosagetext>
        <drugindication>SEDATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558637-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12040823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>2 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORBITOL 50PC INJ</medicinalproduct>
        <drugdosagetext>30 MILLILITER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>5.7143 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>400 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>20 MILLIEQUIVALENTS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugdosagetext>240 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>800-160MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSFUSION</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>18.75 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>18.75 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>90 MCG, 1 INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UP TO 1600MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRBC</medicinalproduct>
        <drugdosagetext>2 UNITS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1091423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558641-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-796330</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>FORM: PRE ORAL AGENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558642-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-OPTIMER-20110054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMODIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111106</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFLURIA</medicinalproduct>
        <drugdosagetext>0.5 ML ONCE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>2-10 UNITS 3 X DAY BEFORE MEALS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>25 MG/ML, 1 ML Q 6 H PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugdosagetext>2.5 MG/3 ML (0.083%)</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>0.02% SOLUTION, 2.5 ML BY NEB AS DIRECTED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>125 MG/2ML, 2 ML BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL 250+D</medicinalproduct>
        <drugdosagetext>1 TAB 3 TIMES DAILY WITH MEALS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1,000 MCG/ML EVERY MONTH X 1 YEAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>1 PUFF  2 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>RENAL IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORASTOR</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>125 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111104</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>7.5-3.25 MG 1 TABLET TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>2-10 UNITS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG/2 ML, 2 ML Q 6 H PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFICID</medicinalproduct>
        <drugauthorizationnumb>201699</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROSE</medicinalproduct>
        <drugdosagetext>25 ML, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>2-4 MG Q 2 H PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111111</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugdosagetext>9 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-1080957</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558644-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1081957</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>LAST DOSE ADMINISTERED 432 MG ON 05/JUNE/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEGF0444A (ANTI-EGFL7)</medicinalproduct>
        <drugdosagetext>LAST DOSE - 05/JUNE/2012, 605 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>918460</drugbatchnumb>
        <drugdosagetext>LAST DOSE ADMINISTERED 1575 MG ON 05/JUNE/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>LAST DOSE ADMINISTERED WAS 929 MG ON 05/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558645-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYMUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPH NODE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QPM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QPM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUACT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558646-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-UCBSA-062635</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>3 LOADING DOSES</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558647-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CHPA2012US014867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN                              /00070002/</medicinalproduct>
        <drugdosagetext>1 SPRAY PER NOSTRIL, QD</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugbatchnumb>23978485</drugbatchnumb>
        <drugdosagetext>1-2 SPRAYS PER NOSTRIL, TWICE DAILY OR MORE IF NEEDED</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558648-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERDIEM FIBER</medicinalproduct>
        <drugdosagetext>UNK, EVERY NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERDIEM OVERNIGHT RELIEF PILLS</medicinalproduct>
        <drugbatchnumb>25984401</drugbatchnumb>
        <drugdosagetext>2 DF, AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US001883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10074656</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10074656</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10074656</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011219960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>1420769</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012118827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.889</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENOUS PRESSURE JUGULAR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012135368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, ONE EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE</medicinalproduct>
        <drugdosagetext>50 MG, 1 NIGHTLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
        <drugdosagetext>25 MG, (1 NIGHTLY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558656-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012148664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALAN SR</medicinalproduct>
        <drugauthorizationnumb>019152</drugauthorizationnumb>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558657-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012181727</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558658-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN049446</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 UG, UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558659-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012186794</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMALINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DENTAL CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDYS</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012177623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558661-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2012143222</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONO-CEDOCARD</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEEN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558662-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012182278</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>200 MG, 3X/DAY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558663-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-2012-076612</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE URINARY TRACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE 75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEVETENS</medicinalproduct>
        <drugdosagetext>DAILY DOSE 600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-FRI-1000037411</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugauthorizationnumb>21742</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>3000 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558665-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0056541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120707000</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALLORY-WEISS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120708754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558668-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558669-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558670-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP SURGERY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558671-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-UCBSA-059472</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GILEAD-2012-0057945</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTIDE</medicinalproduct>
        <drugauthorizationnumb>020638</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEPHROPATHY TOXIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLIAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>500 UNKNOWN, Q3WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960865-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INTRAABDOMINAL FLUID COLLECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN D DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-12P-153-0961665-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558675-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>JMLX6</drugbatchnumb>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2008-188696-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>CONTINUING: NO</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041020</drugenddate>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>DOSE TEXT: 1 TAB OD PRN, FREQUENCY: PRN</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110728</drugenddate>
        <drugtreatmentduration>723</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120209555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugauthorizationnumb>020193</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACID REFLUX MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugdosagetext>100 MG PLUS 100 MG IN AM AND 100 MG PLUS 100 MG IN PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS INTERSTITIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20110808910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GROWTH HORMONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558681-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120705328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>3-5 DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
        <drugauthorizationnumb>20210</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL MOTILITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHELATED MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>2 SPRAY/NOSTRIL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SNORING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>UNSPECIFIED DATE IN MAR- RESTARTED (ILLIGEBLE DOCUMENT)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISAPRIDE</medicinalproduct>
        <drugauthorizationnumb>022331</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>ONCE, A COUPLE OF NIGHTS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>PL-JNJFOC-20110507281</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRIDOXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-UCBSA-062678</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-FRI-1000036842</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>021323</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREDAPTIVE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011035</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL RETARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02852</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOSCOPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAECUM OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugauthorizationnumb>021526</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-FRI-1000037298</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOFEN PUMP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSDERM SCOP PATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120705326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>141522E</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0915655-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATYPICAL MYCOBACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071015</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM HYDRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERIATE W/GENTAMICIN SULFATE</medicinalproduct>
        <drugindication>DERMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG/WEEK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-12P-020-0952108-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugdosagetext>250MG/5ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-12P-153-0961674-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugbatchnumb>66795</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-FRI-1000037440</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>120 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>120 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN SULFATE SODIUM (+) GLUCOSAMINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558708-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558709-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP008236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
        <drugtreatmentduration>100</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558710-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2012-0058300</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-FRI-1000029233</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugdosagetext>200 MICROGRAM, BID</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-FRI-1000037481</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-FRI-1000030916</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIODYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACAMPROSATE</medicinalproduct>
        <drugauthorizationnumb>21431</drugauthorizationnumb>
        <drugdosagetext>6 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0962299-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HELLP SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-FRI-1000037486</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16588BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugauthorizationnumb>021742</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351127USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugbatchnumb>45C019</drugbatchnumb>
        <drugauthorizationnumb>076999</drugauthorizationnumb>
        <drugdosagetext>75 MILLIGRAM;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>325 MILLIGRAM;</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUNNEL VISION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPIDS DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011146</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugtreatmentduration>1136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558727-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-FRI-1000037516</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>021323</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558728-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558729-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350722USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>061926</drugauthorizationnumb>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>HELICOBACTER INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558730-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1071225</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE ON 12/SEP/2011</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1085958</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>3 WEEKS ADMINISTRATION FOLLOWED BY 1 WEEK REST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1078295</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558733-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1074518</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-675480</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE AND DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558736-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1060637</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMYALGIA RHEUMATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE 20/JAN/2011</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP011818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558738-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963015-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963005-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558741-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0962884-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926337-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>6 TABLETS WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1MG QD AS DIRECTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + D</medicinalproduct>
        <drugdosagetext>600-200MG UNIT TABLET QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558743-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963013-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963020-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558745-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963012-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558746-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963003-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558747-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963017-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558748-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963018-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558749-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963010-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558750-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963011-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558751-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963007-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558752-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963014-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558753-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963021-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963016-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ABBOTT-12P-161-0963009-00</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugauthorizationnumb>021312</drugauthorizationnumb>
        <drugdosagetext>2.5/ 120 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASAL CONGESTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-009507513-2011SP060150</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MILD MENTAL RETARDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINE MOTOR DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILAFON</medicinalproduct>
        <drugauthorizationnumb>010775</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-009507513-1207GRC006940</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 UNK, UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1205USA02111</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP043796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOMILEUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091002</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090929</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POTENTIATING DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARB IB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA008186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 MICROGRAM, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558764-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugdosagetext>750 MG, TID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>1CO7004</drugbatchnumb>
        <drugdosagetext>150 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA01680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
        <drugtreatmentduration>689</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
        <drugtreatmentduration>1631</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA005264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY DYSPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugauthorizationnumb>018878</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PATENT DUCTUS ARTERIOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1204USA02815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MSD-1207JPN000299</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME UNCLASSIFIABLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100402</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101008</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101231</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE D</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
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        <drugindication>CONSTIPATION</drugindication>
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        <drugstartdate>20080716</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080314</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
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        <drugenddate>20091109</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100710</drugstartdate>
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        <drugenddate>20100723</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101023</drugstartdate>
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        <drugenddate>20101105</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110506</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110617</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111029</drugstartdate>
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        <drugenddate>20111111</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
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        <drugenddate>20091108</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
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        <drugtreatmentduration>1</drugtreatmentduration>
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      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
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        <drugenddate>20100625</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110115</drugstartdate>
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        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110212</drugstartdate>
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        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111119</drugstartdate>
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        <drugenddate>20111202</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
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        <drugenddate>20120302</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100417</drugstartdate>
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        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110716</drugstartdate>
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        <drugenddate>20110729</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111210</drugstartdate>
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        <drugenddate>20111223</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>UNK, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100220</drugstartdate>
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        <drugenddate>20100305</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
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      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100828</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
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        <drugenddate>20101203</drugenddate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110806</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugdosagetext>24 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100123</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110312</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110402</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110625</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111008</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091225</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091127</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110514</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
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        <drugdosagetext>200 MG, UNK</drugdosagetext>
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      <drug>
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        <medicinalproduct>VORINOSTAT</medicinalproduct>
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        <drugdosagetext>UNK</drugdosagetext>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
        <drugauthorizationnumb>021991</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
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      <drug>
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        <medicinalproduct>VORINOSTAT</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
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        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111231</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT</medicinalproduct>
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      <drug>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558769-0</safetyreportid>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA003568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
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        <drugcharacterization>1</drugcharacterization>
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    </patient>
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    <safetyreportid>8558770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA03890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
        <drugtreatmentduration>3285</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA02446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL POLYPECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAPULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
        <drugtreatmentduration>5110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COMMINUTED FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MERALGIA PARAESTHETICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORIMOTOR NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN-VASCULAR DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
        <drugtreatmentduration>689</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>2043</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30-45</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>7350</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>3507</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>35 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500-1000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>75 ?G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>20 IU, HS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MSD-1207ESP006958</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE/SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>22044</drugauthorizationnumb>
        <drugdosagetext>50MG/1000MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>383</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMPRIDA</medicinalproduct>
        <drugdosagetext>5MG/160MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP033532</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-2012SP036741</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>64 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEBETINA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0805</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.4 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>64 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>2.4 MG/M2, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0805</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP030917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>UPDATE (19JUN2012): TABS 2'S</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>022277</drugauthorizationnumb>
        <drugdosagetext>140 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 PUFFS, PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MK-3034</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091114</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MGM, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>3 DF BID, TOTAL DOSE 1000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091114</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>120/0,5 MG</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091114</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINES</medicinalproduct>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>30 MG, Q4H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLLICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROINTESTINAL PREPARATIONS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-009507513-1207AUS008501</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADON HCL TAB</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>2600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-1207CAN009352</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, HS</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNCTIONAL RESIDUAL CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70  MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>2123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
        <drugtreatmentduration>2123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEURIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011120</drugenddate>
        <drugtreatmentduration>1451</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70/5600</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090122</drugenddate>
        <drugtreatmentduration>2621</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70/2800</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
        <drugtreatmentduration>891</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
        <drugtreatmentduration>305</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL SMALL VESSEL ISCHAEMIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
        <drugtreatmentduration>3142</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010326</drugenddate>
        <drugtreatmentduration>575</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0152</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POSTMENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>6570</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
        <drugtreatmentduration>1281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1109USA01913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CULTURE URINE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERNICIOUS ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS POSTMENOPAUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCOMMODATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS PROPHYLAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATREXEL</medicinalproduct>
        <drugdosagetext>2.5 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>3461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>6-30</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugtreatmentduration>5475</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>3629</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9039</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA04986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558788-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA003285</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1 DF, TIW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLAXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1800 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-009507513-1207AUS007752</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>30-60 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTRON A</medicinalproduct>
        <drugdosagetext>0.5 MILLION IU, Q3W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9355</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-009507513-1206DEU00028</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>610</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP014009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN INTRACRANIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARBUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042046NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100107</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0962122-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>011</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP011827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558797-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-MSD-1206USA03831</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VEIN DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>900 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAGNOR</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>16 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>900 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>90 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-009507513-1207BRA013030</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY CESSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugauthorizationnumb>021165</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROAT IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>THROAT IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERTIX</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN008381</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
        <drugauthorizationnumb>020497</drugauthorizationnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1205USA00026</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE INVERSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APREPITANT</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugdosagetext>125 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>59 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>63 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>12 ML, ONCE</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE</medicinalproduct>
        <drugdosagetext>1.3 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>15 ML, TID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APREPITANT</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugdosagetext>80 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APREPITANT</medicinalproduct>
        <drugauthorizationnumb>021549</drugauthorizationnumb>
        <drugdosagetext>80 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>8 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>8 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1000 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FLUID REPLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugdosagetext>90 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120415</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120415</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMETOP</medicinalproduct>
        <drugdosagetext>40 MG, ONCE</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558801-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA05008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITIONAL SUPPLEMENTS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DECREASED APPETITE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>20386</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE INJ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GIMERACIL (+) OTERACIL POTASSIUM (+) TEGAFUR</medicinalproduct>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>METASTATIC GASTRIC CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1204USA03831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugdosagetext>100MG-12.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugdosagetext>50MG-12.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010282</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>297</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>256</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugbatchnumb>11-JS-1</drugbatchnumb>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugdosagetext>TWO INHALATIONS ONCE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558805-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1109USA01760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANIMAL BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091214</drugenddate>
        <drugtreatmentduration>426</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010102</drugenddate>
        <drugtreatmentduration>1742</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>670</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>3243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558806-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1204USA00884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BINGE EATING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACKED RED BLOOD CELL TRANSFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAUSTROPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHING'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAGNESIUM METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558807-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREARM FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK FIRST DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUTY ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASODILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020201</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060131</drugenddate>
        <drugtreatmentduration>1442</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558808-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA00845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUTURE RELATED COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100104</drugenddate>
        <drugtreatmentduration>638</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE LOSS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110207</drugenddate>
        <drugtreatmentduration>320</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558809-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE IIB HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558810-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIBIOTIC LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE COMPONENT ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS SOFT TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
        <drugtreatmentduration>2008</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>4745</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558812-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558813-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201042115NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugbatchnumb>01815D</drugbatchnumb>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugdosagetext>90 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN [INSULIN]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 370</medicinalproduct>
        <drugauthorizationnumb>020220</drugauthorizationnumb>
        <drugindication>NASAL CAVITY MASS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558814-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012US006459</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOLOGICAL THERAPY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558815-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-MSD-2012SP033117</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558816-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558817-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-009507513-1207ESP011058</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558818-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-061414</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOPROSTOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: QS PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558819-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOMARINP-001765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERFORATED ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KUVAN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022181</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PHENYLKETONURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558820-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-042888-12</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF CRIME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>DOSING DETAILS UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558821-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-042890-12</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POSTPARTUM DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>UNIT DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558822-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-039868-12</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>L11GW105</drugbatchnumb>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>2 STRIPS DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>L11GW105</drugbatchnumb>
        <drugauthorizationnumb>022410</drugauthorizationnumb>
        <drugdosagetext>1/2 STRIP TWICE DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-042944-12</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>DRUG DEPENDENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSING DETAILS UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020732</drugauthorizationnumb>
        <drugdosagetext>DOSING DETAILS UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-201046823GPV</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100307</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>240 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558825-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0959706-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSITIONAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558826-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201041518NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558827-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0936127-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558828-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-12P-153-0940880-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOPULMONARY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558829-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-350027ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMINA UMANA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugauthorizationnumb>020747</drugauthorizationnumb>
        <drugdosagetext>400 MICROGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558830-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA012070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>21067</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558831-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN G DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN M DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIDESONIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLINE (ALBUTEROL SULFATE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558832-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350259ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugauthorizationnumb>078058</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558833-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-001027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558834-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-001169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201110006806</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugauthorizationnumb>021773</drugauthorizationnumb>
        <drugdosagetext>5 UG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558836-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000929</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>40 MG, M-F</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558837-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350263ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON MR</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076052</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558838-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350267ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN HEARING LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugauthorizationnumb>074067</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558839-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558840-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-001801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONTINUOUS</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558841-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-001690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558842-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350275ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>076846</drugauthorizationnumb>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558843-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AP-00608AP</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINOX (LERCANIDIPINE, HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMABEL (DIAZEPAM)</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSCOL (HYOSCINE, BUTYLBROMIDE)</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 MCG</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558844-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110125</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2011-001985</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIONAMIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSERINE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALGANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>021277</drugauthorizationnumb>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>ORAL CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOFAZIMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558845-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-002033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPRO</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugindication>PROSTATE INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558846-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558847-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350285ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076052</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558848-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-002414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugauthorizationnumb>021085</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558849-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GRANULOMATOUS LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, Q8H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558850-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA009871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>12 MICROGRAM, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MICROGRAM, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>201</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558851-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558852-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DR. SCHOLL'S SMALL CORN REMOVERS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERKERATOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558853-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AT065088</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANCOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBRANTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558854-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012ID066115</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558855-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>018704</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065392</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>16608</drugauthorizationnumb>
        <drugdosagetext>150 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558857-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX REGIONAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF (320/10 MG), UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558858-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA064189</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558859-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP062495</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPESVIRUS 6 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST TRANSPLANT DISTAL LIMB SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>BONE MARROW TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558860-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BE061327</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558861-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558862-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US07761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558863-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR044968</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>1 DF, , FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>FROM 2 YEARS AGO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
        <drugdosagetext>0.5 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPA</medicinalproduct>
        <drugdosagetext>4 DF, DAILY, FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>1 DF, FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugdosagetext>1 DF, FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugdosagetext>1 DF, FROM ONE YEAR AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5MG/100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CALCIUM METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL MR</medicinalproduct>
        <drugdosagetext>2 DF, FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>1 DF, FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOLOFIN</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERA D3</medicinalproduct>
        <drugdosagetext>10 DRP, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETENIC</medicinalproduct>
        <drugdosagetext>1 DF, FROM 2 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>2 DF, DAILY, FROM 2 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISAR</medicinalproduct>
        <drugdosagetext>HALF TABLET IN THE MORNING AND HALF TABLET AT NIGHT, FROM 2 YEARS AGO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>2 DF, PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITONEURIN</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558864-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US007361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
        <drugtreatmentduration>276</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558865-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX066069</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, EACH YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558866-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012ZA066127</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG PER 100 ML YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558867-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066108</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>Z0095</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF (160/12.5 MG), DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012RU065830</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558869-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558871-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558872-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, ONCE ANNUALLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558873-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558874-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB000641</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
        <drugtreatmentduration>1975</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558875-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA001263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>1CO7004</drugbatchnumb>
        <drugdosagetext>150 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558876-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP035044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugbatchnumb>458324</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558877-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-350295ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>074739</drugauthorizationnumb>
        <drugdosagetext>200 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMINA CLORIDRATO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558878-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350425ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>ONGOING</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>88627</drugauthorizationnumb>
        <drugindication>NECK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>ONGOING</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>500MG/50</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>500MG/50MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558880-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>850 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>10 IU, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugdosagetext>120 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>4 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTISPORIN CREAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 MICROGRAM, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558881-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA009927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558882-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558883-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558884-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTRIMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>1 GTT, 4*/DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>12 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>200 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>1 GTT, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERA TEARS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE - USP</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, ONE PILL ONCE A DAY AND TWO PILLS ONCE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BILBERRY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558885-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US002665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN TENSION HEADACHE CAPLETS</medicinalproduct>
        <drugbatchnumb>10110271</drugbatchnumb>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558886-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>AS NEEDED ONCE OR TWICE A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19750101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19940101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558887-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER W/ WHEAT DEXTRIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558888-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US006230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA CR</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ARTHRITIS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS RS LIQ COOL MINT</medicinalproduct>
        <drugbatchnumb>10109533</drugbatchnumb>
        <drugdosagetext>1 TSP, 6QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BELLADONNA EXTRACT</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558889-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US014904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>8 TO 10 DF, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>6 DF, A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>10125253</drugbatchnumb>
        <drugdosagetext>2 DF, Q4H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558890-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558891-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER W/ WHEAT DEXTRIN</medicinalproduct>
        <drugbatchnumb>26274003</drugbatchnumb>
        <drugdosagetext>1 TSP, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558892-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016127</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10102533</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>2 TO 4 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>1 1/2DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558893-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-002737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.295</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAVIST 150</medicinalproduct>
        <drugbatchnumb>03810A</drugbatchnumb>
        <drugauthorizationnumb>021425</drugauthorizationnumb>
        <drugdosagetext>80 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM ABDOMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101217</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558894-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA009797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558895-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558896-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POTENTIATING DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXACILLIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUSIDIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558897-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-350485ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>022160</drugauthorizationnumb>
        <drugdosagetext>85 MG/M2;</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDO FOLINICO</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558898-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558899-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558900-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558901-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558902-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558903-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DR. SCHOLL'S ULTRA THIN CORN REMOVER</medicinalproduct>
        <drugbatchnumb>1H7091</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558904-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYPROTERONE ACETATE</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHANGE OF BOWEL HABIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>180 MICROGRAM, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>200MG,4TABLETS,THREE TIMES A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180MCG,ONCE A WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECHINACEA (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558906-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugdosagetext>40 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALBUTAMOL SANDOZ (ALBUTEROL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADEINE (ACETAMINOPHEN (+) CODEINE PHOSPHATE)</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.306</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY ANASTOMOTIC LEAK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>40 MG/ML, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0,5 TO 0.2 MG EVERY SIX HOURS</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugindication>METASTATIC NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
        <drugdosagetext>2000 UNIT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558908-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-QUU411841</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091223</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100128</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558909-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961534-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558910-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120801</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960754-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORETHINDRONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020011</drugauthorizationnumb>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558911-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, HS</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558912-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012032277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.213</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>135 MUG, QWK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MEQ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558913-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558914-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011029540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1024202A</drugbatchnumb>
        <drugdosagetext>80 MUG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101217</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558915-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012029580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIDOVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugbatchnumb>1030081</drugbatchnumb>
        <drugdosagetext>5 MUG/KG, UNK</drugdosagetext>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558916-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558917-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16256BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558918-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16255BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2012S1014695</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>090650</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 2.5 MG MILLGRAM(S) EVERY DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558920-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011042118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>160.54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NPLATE</medicinalproduct>
        <drugdosagetext>1 MUG/KG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110105</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>875 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101202</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558921-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014778</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065195</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558922-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014779</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>FUNCTIONAL GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugauthorizationnumb>072741</drugauthorizationnumb>
        <drugindication>FUNCTIONAL GASTROINTESTINAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558923-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MYLANLABS-2012S1014807</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>075755</drugauthorizationnumb>
        <drugdosagetext>1X DAAGS 1 CAPSULE 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558924-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012015969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558925-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-MYLANLABS-2012S1014981</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCITRATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558926-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-009507513-2010SP060672</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOXAFIL</medicinalproduct>
        <drugauthorizationnumb>022003</drugauthorizationnumb>
        <drugdosagetext>7.5 ML, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC GRANULOMATOUS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>CHRONIC GRANULOMATOUS DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558927-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558928-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2012036732</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>8 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMATIL</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>6 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111221</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558929-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2012S1014989</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>091590</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558930-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MYLANLABS-2012S1014989</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>075640</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558931-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028484</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>4702</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCRYS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IR-MYLANLABS-2012S1015234</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>077567</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THIORIDAZINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2012S1012806</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DRUG INTAKE BY CHILD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>76792</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16753048</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>0.1%</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>1DF= TABS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558935-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-16818932</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0958553-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL DEPOSITS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16742785</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANPLAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRINZMETAL ANGINA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRINZMETAL ANGINA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HICCUPS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>CAP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>S-1</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRINZMETAL ANGINA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXALTIN</medicinalproduct>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HACHIAZULE</medicinalproduct>
        <drugindication>STOMATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16797359</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1 DF: 200MG/245MG</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP014867</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, Q8H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPREX</medicinalproduct>
        <drugdosagetext>4000 UNITES</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
        <drugtreatmentduration>128</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558943-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010478</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>50/500MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558944-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALBUTEROL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.63MG/3ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE (+) GUAIFENESIN</medicinalproduct>
        <drugdosagetext>5 ML, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 MICROGRAM, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugdosagetext>5 ML, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>80/4.5 MCG, 2 PUFFS TO TIMES</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>134 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugauthorizationnumb>18558</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>80/4.5 MCG, 2 PUFFS TO TIMES</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE (+) CHOLECALCIFEROL</medicinalproduct>
        <drugdosagetext>2000 IU, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>2 DF, 4 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558945-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR001662</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXCESSIVE GRANULATION TISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugbatchnumb>969069/228934</drugbatchnumb>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012047275</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFLANIL</medicinalproduct>
        <drugdosagetext>7.5MG DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POTENTIATING DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
        <drugdosagetext>900 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
        <drugdosagetext>680 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558949-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYSTIC KIDNEY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558950-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558951-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009713</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558952-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP028897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugbatchnumb>120022</drugbatchnumb>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN001345</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE VALERATE</medicinalproduct>
        <drugauthorizationnumb>014215</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
        <drugtreatmentduration>109</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEBENIN</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YUNASUPIN</medicinalproduct>
        <drugdosagetext>4.5 G, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugdosagetext>999 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZORAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ERYTHEMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSEUDOMEMBRANOUS COLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>60 MICROGRAM, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATADINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120506</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>1000 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ERYTHEMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>60 MICROGRAM, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEBENIN</medicinalproduct>
        <drugdosagetext>3 G, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugdosagetext>999 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER (DIFLUPREDNATE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER (DIFLUPREDNATE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558955-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugauthorizationnumb>019462</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRO-DUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558956-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>3 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558957-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2012042053</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2-3 TIMES PER WEEK.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021688</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558961-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558962-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PAR PHARMACEUTICAL, INC-2012SCPR004513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>RHINORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM ER TABLETS</medicinalproduct>
        <drugauthorizationnumb>78445</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>1 DF, / DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SNEEZING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE RUPTURE OF MEMBRANES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX DYSTOCIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILED INDUCTION OF LABOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MSD-1206USA04977</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>21995</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013101</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012046456</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICLOSAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-AMGEN-COLCT2012033614</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPREDNISONE</medicinalproduct>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>631</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE41513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21228</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>2.5-0.25 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>WITH FOOD OR MILK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN XL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugdosagetext>50 MG TABLET TAKE ONE TABLET AT ONSET OF HEADACHE AND REPEAT IN TWO HOURS IF NEEDED</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>5MG-500MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUT/ASA/CAFF</medicinalproduct>
        <drugdosagetext>TAKE ONE CAPSULE EVERY SIX HOURS AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>10 MG-650 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMACOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugdosagetext>325-40-50</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
        <drugdosagetext>TAKE ONE TABLET 4 TIMES DAILY AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>WITH FOOD OR MILK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>7.5-325 MG TAKE ONE TABLET EVERY SIX HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2012044171</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-ALPHA</medicinalproduct>
        <drugdosagetext>0.25 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>314</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>1043</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110329</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HANGE-SHASHIN-TO</medicinalproduct>
        <drugdosagetext>2.5 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>1427</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, EVERY 2 WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1044</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558972-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558973-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558974-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-NO-1108S-0789</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugbatchnumb>11218757</drugbatchnumb>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558975-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558977-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16138547</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugindication>TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>THERAPY ON 23MAY11,06JUN11,04JUL11,01AUG11,29AUG11</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558978-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16803405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SAXAGLIPTIN</medicinalproduct>
        <drugauthorizationnumb>22350</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558979-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16516585</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugbatchnumb>1G64569</drugbatchnumb>
        <drugdosagetext>INF:6, LAST INF: 19-JUL-12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMON OIL</medicinalproduct>
        <drugdosagetext>WILS SALMON OIL</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558980-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-16795130</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558981-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16722175</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>INTER ON 8JUN12 NO OF DOSES 4 LAST DOSE ON 7JUN12,8JUN12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558982-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16416349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>132</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1DF=1000 U</drugdosagetext>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>1DF=2TABS</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
        <drugdosagetext>COURSE NUMBER: 1.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
        <drugindication>FLATULENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IXABEPILONE</medicinalproduct>
        <drugdosagetext>32MG:15FEB12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16781148</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>NO OF INFUSIONS :2</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558984-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558985-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINDOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558986-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010706</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNARIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SANDOZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558987-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FORCED EXPIRATORY VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFONMETHANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZASITE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTAZYM CAPSULES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLISTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>1.5-2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558988-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-16792251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558989-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16792269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugauthorizationnumb>18207</drugauthorizationnumb>
        <drugdosagetext>4.5G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>EXTENDED RELEASE,DOSE:13.5G</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>90MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>1.8G</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558990-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-16797771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>018057</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE ON 28MAY2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCOF</medicinalproduct>
        <drugbatchnumb>01753001</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED DISODIUM</medicinalproduct>
        <drugdosagetext>LAST DOSE ON 28MAY2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558991-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI024093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX REGIONAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL COLUMN MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558992-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI011581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOCUMENTED HYPERSENSITIVITY TO ADMINISTERED DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110119</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558993-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI023005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558994-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI002446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CERVIX CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558995-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI016404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120206</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558996-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558997-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI020748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS ESCHERICHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UHTHOFF'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558998-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI022796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8558999-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI023194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SERUM SICKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559001-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2012BI025793</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVORIL (LORAZEPAM)</medicinalproduct>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559002-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559004-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATOFIBROSARCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559005-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2012BI027768</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSVERSE SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559008-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2010BI030660</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI040940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELAYED RECOVERY FROM ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559010-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI012230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32148</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559011-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI014885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI037188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559013-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI039733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32145</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559014-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI039938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111004</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI004547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-BIOGENIDEC-2012BI008549</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559017-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI012088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI020061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2012BI021963</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BIOGENIDEC-2012BI023683</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559021-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559022-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559023-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027327</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE ANASTOMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559025-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2012BI027720</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2012BI027721</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32158</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32166</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BIOGENIDEC-2012BI027922</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC DISC DRUSEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32167</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32161</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32166</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32165</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI042477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI009336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI010660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI022161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI022309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559040-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI023304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559042-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559043-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559044-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559045-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559046-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081003</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559051-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559052-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111021</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559057-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559058-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559060-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SPECIFIC ANTIBODY PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027792</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559070-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL IMPLANTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559082-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559084-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRADUCTAL PAPILLOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFERTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559089-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559090-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559091-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBESITY SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559094-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559095-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI016979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION (NOS)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GAIT DISTURBANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559098-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI022984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P41010</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI024692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559100-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559101-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559102-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559103-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32168</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559104-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559105-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559111-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P41010</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071031</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P41009</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P41010</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559117-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027418</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559122-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P41010</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559124-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R32015</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559125-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559126-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080829</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559128-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559129-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559130-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559131-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559132-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027821</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559133-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559135-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559136-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559137-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559138-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559139-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P41010</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559140-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559141-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG,ONCE IN THREE DAYS</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559143-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-2010SP039100</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCAPNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugdosagetext>100 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>REPORTED AS INNOVAIR (BECLOMETASONE, FORMOTEROL)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE (+) MAGNESIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugdosagetext>200 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>50 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugdosagetext>100 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugdosagetext>10 ?G, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAESTHETIC PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAROPIN</medicinalproduct>
        <drugdosagetext>20 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEUROMUSCULAR BLOCKADE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>020214</drugauthorizationnumb>
        <drugdosagetext>50 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GENERAL ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugdosagetext>40 ?G, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAIT DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559145-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCLAVIAN ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST-T SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIFFERENCE OF EXTREMITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010755</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugdosagetext>2 G, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA008564</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GRANULOMATOUS LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, Q8H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-009507513-1207DEU012621</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-061848</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00E4K</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG TOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>900 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1125 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-009507513-1207CHE009925</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>GASTROSTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>GASTROSTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOFLUID</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugindication>GASTROSTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXURA</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugindication>GASTROSTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>GASTROSTOMY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559162-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP025870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559163-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559164-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559165-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA00936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559166-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-068951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00DGE</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559167-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028241</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2012047254</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1020 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>COLONY STIMULATING FACTOR PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>128 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100126</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-009507513-1207BEL011601</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559171-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MSD-1207GBR012288</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>75 MG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL TABLETS BP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2012047004</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559179-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011060371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559180-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLOW SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP032814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>EVERY 3 YEARS</drugdosagetext>
        <drugadministrationroute>059</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TATRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERODUAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, HS</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559198-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208CAN000295</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>021249</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-MSD-1208MEX000231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>549</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugauthorizationnumb>020386</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959388-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15394703</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>POTASSIUM CHLORIDE 20MEQ CAPS 3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>METOPROLOL TARTRATE 25 MG TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>PROMETHAZINE HCL 25MG TABS EVERY 8 HRS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>DIOVAN HCT 160-25 MG TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>VITAMIN D3 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>4 TIMES A DAY</drugdosagetext>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>ALPRAZOLAM 0.25MG TABS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>FUROSEMIDE 20MG TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>.NO OF COURSES=1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>SYNTHROID 100 MCG TABS,125 MCG TABS FIR A TOTAL OF 225 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>ZOFRAN 8MG TABS EVERY 8 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>PERCOCET 5/325MG TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>CENTRUMSILVER TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>COUMADIN 5MG TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>EQL OMEPRAZOLE 20 MG TBEC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BRISTOL-MYERS SQUIBB COMPANY-16795536</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFEPIME</medicinalproduct>
        <drugauthorizationnumb>050679</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugauthorizationnumb>019763</drugauthorizationnumb>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>EWING'S SARCOMA METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NETROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559212-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-16556086</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>STOPPED:17APR12 RESTARTED:17APR12-ONG 1 MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>MAR2012-08APR12 4 MG 1MON 11APR12-13APR12 8 MG 2D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITICAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ON DY1 AND DY 8 OF EACH 3WEEK CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>MAR2012-08APR12 4 MG 1MON 11APR12-13APR12 8 MG 2D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>16APR12 16APR12-23APR12  8 MG 7D 23APR12-24 APR12 4 MG 1D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugbatchnumb>01053601</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>E06381-002L01</drugbatchnumb>
        <drugdosagetext>PRODUCT STRENGTH IS 5MG/ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>10APR12 11APR12-12APR12 1D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CILENGITIDE</medicinalproduct>
        <drugbatchnumb>CT2584/4</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYSTEN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CACIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559215-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-16812745</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRAUMATIC HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559216-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14337356</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPHYSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16798621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugindication>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTAZ</medicinalproduct>
        <drugdosagetext>Q24H OVER 30 MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>BEFORE BREAKFAST</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>1DF:325-650MG  Q4H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugdosagetext>Q6H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>MONDAY,WEDNESDAY AND FRIDAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FATTY ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16599730</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>20357</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugdosagetext>40IU ALSO TAKEN 27NOV11-16AUG11 9FEB11-16AUG11 INJ</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>1DF=8 TO 18IU AT EACH MEAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559223-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEON</medicinalproduct>
        <drugdosagetext>1 DF, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACEON</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugauthorizationnumb>021687</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-071960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU009NP</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>408</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSPLANT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROERGOTAMINE MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>88 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>20 G, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>50000 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugtreatmentduration>738</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>70 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVOPROST</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559248-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351406USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-AMGEN-COLSP2012043614</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>40/12.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559250-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-AMGEN-CZESP2012023520</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LATENT TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-VERTEX PHARMACEUTICALS INC.-000000000000001265</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559257-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2012046450</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, EVERY TWO WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
        <drugtreatmentduration>792</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVANTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003983</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MSD-1207DEU009265</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>50MG/850MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111121</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012DE011130</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED QVA149</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED TIOTROPIUM</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559264-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP045635</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOREMIFENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>20726</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugauthorizationnumb>020234</drugauthorizationnumb>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559266-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21660-12073140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>021660</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559268-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA042784</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXIRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICLOPIDINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351411USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US010342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALATAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, MONTHLY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065169</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugbatchnumb>110002/11J07DA</drugbatchnumb>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>1 DF, Q12H</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004235</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEREOTYPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUALLY INAPPROPRIATE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL DECANOATE</medicinalproduct>
        <drugdosagetext>500 MG, (WEEKLY)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, QDS PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15 ML, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, TDS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>2000 MG, (NOCTE)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559273-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN057375</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS PROLIFERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY MUSCLE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201102003226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>22307</drugauthorizationnumb>
        <drugdosagetext>60 MG,ONCE</drugdosagetext>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugdosagetext>250/50 UG, 2/D</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>75 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>80 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5 MG, 2/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY (1/D)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US00507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>1 CAPFUL TWICE DAILY FOR 1 MINUTE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559276-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA02009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>823</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>1037</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10  MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050201</drugenddate>
        <drugtreatmentduration>1127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100118</drugenddate>
        <drugtreatmentduration>694</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR035173</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>50 MG,</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX032569</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, ONCE A YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.625 MG, DAILY</drugdosagetext>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 UG, DAILY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOVARTALON</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA87249</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>40 UKN, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 UKN, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>150 MG, Q48H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugbatchnumb>F0010</drugbatchnumb>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US016487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOGENITAL WARTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE AND MOUTH X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSIVE SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METATARSUS PRIMUS VARUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGE-RELATED MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT NUCLEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON                                /NET/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERI-COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>50 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICITRA                            /02399901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE NAPSYLATE W/ ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US015696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.773</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS POLYP DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA IN SITU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMETABOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARESTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/325 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FARESTON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE DENTAL ^ACO^</medicinalproduct>
        <drugdosagetext>.12 %, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559284-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US011884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.09</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.574</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MUCOSAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>1250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR066203</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENSEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011FR19300</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559290-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0041</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559291-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CSF VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559292-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA066253</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA56977</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0169</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US010495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.13</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>4 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugdosagetext>600/400 BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugbatchnumb>16E60053</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/ 100 ML YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA054795</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA17819</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>60 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EEVRY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, ONCE I A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugbatchnumb>F0017</drugbatchnumb>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US07540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF MALIGNANT DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASEDOW'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPYLTHIOURACIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA (MAGNESIUM HYDROXIDE/ALUMINIUM HYDROXIDE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPACOL SORE THROAT + COUGH RELIEF LOZENGES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2 MG, AT BED TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR057607</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>14 DF, QMO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTACARINAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/ 100 ML</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.655</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA37020</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GROWTH HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESENEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559305-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU051153</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HISTIOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST INFLAMMATORY PIGMENTATION CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFAZIMINE</medicinalproduct>
        <drugauthorizationnumb>19500</drugauthorizationnumb>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NODULAR VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559306-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011IT95310</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONADORELIN INJ</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLVADEX</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066044</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLOPA</medicinalproduct>
        <drugdosagetext>0.25 DF (200/50 MG), TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>305310</drugbatchnumb>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD (9MG/5CM2\ 24 HRS)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>13.3 MG, QD (27MG/15CM2/ 24 HRS)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE HYDROCHLORIDE (ALOIS)</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG, QD (18MG/10CM2\ 24 HRS)</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011TH107012</companynumb>
    <primarysource>
      <reportercountry>THAILAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG PER MONTH</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003365</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559310-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NZ065829</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT066039</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPONIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MISOFENAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID (160 MG DAILY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>146</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559312-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR052646</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODOPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>19758</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>155</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIANSERINE G GAM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACID ALENDRONIQUE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT066166</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT065963</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>600 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>178</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559315-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-065742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>BA7810A</drugbatchnumb>
        <drugdosagetext>8 MIU, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPREAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NL066197</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0045</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML ONCE PER 84 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0033</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML ONCE PER 84 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0008</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML ONCE PER 84 DAYS</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2011GB01821</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA066259</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559319-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR066227</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>320 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US010063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>3.125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMNESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, Q18H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK UKN, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, ONCE A YEAR</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugdosagetext>1 CAPSULE, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>1 TABLET, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>13 U, QD</drugdosagetext>
        <drugindication>BLOOD INSULIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETHANECHOL CHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559321-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012NL010219</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugdosagetext>360 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>362</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>362</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLBUTAMIDE</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugindication>HYPERGLYCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559322-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA92370</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR041958</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPOSURE VIA PARTNER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>FETAL DRUG EXPOSURE VIA PARTNER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559324-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP12245</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECONDARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070711</drugenddate>
        <drugtreatmentduration>156</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN060483</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BE009345</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugindication>SICKLE CELL ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA040073</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US01632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.156</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIFICATION METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MUCOSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051010</drugenddate>
        <drugtreatmentduration>708</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>3.5 MG MONTHLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559330-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA064188</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY PAPILLOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004254</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED HYDROCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NILOTINIB</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA066258</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA065374</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA56043</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, EVERY 6 MONTHS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONCE IN A MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE066214</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400-500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011042640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.202</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02848</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATTOKINASE</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD THICKENING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>351</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080121</drugenddate>
        <drugtreatmentduration>2577</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>750</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559344-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NL051902</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML, ONCE EVERY 12 WEEKS</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0033</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML, ONCE EVERY 12 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0038</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML, ONCE EVERY 4 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559345-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA78088</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATOLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PANCREATITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110830</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IR066126</companynumb>
    <primarysource>
      <reportercountry>IRAN (ISLAMIC REPUBLIC OF)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>ONCE A DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>ONCE A DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>21882</drugauthorizationnumb>
        <drugdosagetext>500 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THALASSAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>40-50 MG/KG/DAY (5-7 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THALASSAEMIA BETA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19660101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>2 U, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEFERIPRONE</medicinalproduct>
        <drugdosagetext>TDS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THALASSAEMIA BETA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19660101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>ONCE A DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESFERAL</medicinalproduct>
        <drugdosagetext>60MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559347-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012TR065673</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>4400 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US007124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG ONCE ANNUALLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SENILE OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR058998</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugauthorizationnumb>22334</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110315</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA21334</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, ONCE IN A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY FOUR WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004260</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB02285</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOPROLIFERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>80 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003468</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN018133</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>600 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559356-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003919</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAMPYLOBACTER GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN (LYRICA)</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>275 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA064830</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU028838</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066261</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IL059943</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>60 MG, EVERY 28 DAYS</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>60 MG, EVERY 28 DAYS</drugdosagetext>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR066228</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUMPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZODIAZEPINES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU054602</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugdosagetext>0.5 MG, DAILY(NOCTE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1 G, BD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>650 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL</medicinalproduct>
        <drugdosagetext>150 MG, (EVERY 2 WEEKS)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003147</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT060685</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111103</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>136 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090423</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>136 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
        <drugtreatmentduration>1202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100415</drugenddate>
        <drugtreatmentduration>501</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
        <drugtreatmentduration>447</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111103</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559365-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IL066048</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA050893</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION PARASITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>COLON NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU057196</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>2630</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351335USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NL054598</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICALUTAMIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 28 DAYS</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0038</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0033</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG 1X PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559374-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004274</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>RESTLESSNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU062031</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, ( IN MORNING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>4916</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE BISMUTH</medicinalproduct>
        <drugdosagetext>1700 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>10 MG, (IN MORNING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>900 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHMT2006CA01252</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM AMBULATORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TERMINAL DRIBBLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>50 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>50 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE (PRISOLEC)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>50 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CERZ-1002563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>19.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>60 U/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GENZYME-THYM-1003347</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOOCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMSALYO</medicinalproduct>
        <drugdosagetext>198 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>4800 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugdosagetext>263 MCG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugdosagetext>64 MG, QID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1980 MG, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-2012-073892</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.864</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPRIX [HYDROCHLOROTHIAZIDE,RAMIPRIL]</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111220</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATOMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-020161</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TANATRIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>DAILY DOSE 30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200MG AND 400MG ALTERNATELY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120712426</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120518226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>119.75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED IMMUNE RESPONSIVENESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>40 UNITS/SOLUTION BEFORE MEALS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>DOSE: 75/25, 27 UNITS IN THE MORNING AND 25 UNITS BEFORE DINNER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>52 UNITS/ AT NIGHT/SUBCUTANEOUS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120512652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-BAYER-2012-064893</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GANGRENE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>54027TP</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2011-089136</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG - DOSE REDUCED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-VERTEX PHARMACEUTICALS INC.-000000000000001276</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-VERTEX PHARMACEUTICALS INC.-000000000000000518</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350289ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL POVERTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLUNTED AFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077048</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351120USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-SWECT2012045274</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100128</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091223</drugenddate>
        <drugtreatmentduration>148</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-AMGEN-PRTSP2012046419</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351121USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559401-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>NAA063B</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559402-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559403-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559404-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOTIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559405-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201019469NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.455</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060423</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090315</drugenddate>
        <drugtreatmentduration>1400</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090315</drugenddate>
        <drugtreatmentduration>1521</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIMIGRAINE PREPARATIONS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
        <drugtreatmentduration>1521</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200917548NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOL 1</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugdosagetext>UNK, 750MG-7.5MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201011749NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.819</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DESMOID TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
        <drugtreatmentduration>716</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
        <drugtreatmentduration>716</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090813</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559408-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-003786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>54028V4</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID TUE, THUR, SAT, SUN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>54025L6</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559409-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022365NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>133.79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPIUM ALKALOIDS AND DERIVATIVES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090827</drugenddate>
        <drugtreatmentduration>1225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDENT LD</medicinalproduct>
        <drugdosagetext>1 TWICE A DAY TIMES 5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>875 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCETIRIZINE DIHYDROCHLORIDE</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090615</drugenddate>
        <drugtreatmentduration>1362</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>2 SQUIRTS DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE HCL VISCOUS</medicinalproduct>
        <drugdosagetext>2 %UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>37.5MG/325MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>1948</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071004</drugenddate>
        <drugtreatmentduration>742</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5MG/500MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076193</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-005762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
        <drugdosagetext>100 MG, 1 TABLET EVERY 4 TO 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060817</drugenddate>
        <drugtreatmentduration>1673</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVER SULFADIAZINE</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030609</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
        <drugdosagetext>650 MG, 1 TABLET EVERY 4 TO 6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060817</drugenddate>
        <drugtreatmentduration>1673</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559420-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-028765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090917</drugenddate>
        <drugtreatmentduration>256</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-349284GER</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOPAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOBUTAMINE</medicinalproduct>
        <drugauthorizationnumb>74206</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEPTIC SHOCK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351412USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-CLOF-1002218</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>REFLEXES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTENSOR PLANTAR RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>18 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>3600 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMSACRINE</medicinalproduct>
        <drugdosagetext>220 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAILY FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>REDUCED DOSE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120712706</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>IN CPLD PATIENTS ON DAY 1 AT 4 WEEK INTERVALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>ON DAY 1</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER RECURRENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>IN CP PATIENTS ON DAY 1 AT 3 WEEK INTERVALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAILY FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugdosagetext>DAY 1 DOSE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559437-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120610527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>CAB1H00</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559438-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559439-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00D86</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120421</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077503</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559448-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075103</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00E4K</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-IT-00200IT</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugdosagetext>STRENGTH: 80/12.5;  DAILY DOSE: ONE POSOLOGIC UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559452-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-FF-00426FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACUPAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>4 G</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHIROCAINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugauthorizationnumb>017407</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16558BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-DE-01774DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120712584</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120712758</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugdosagetext>BETWEEN 200 MG DAY 1 AND 400 MG DAY 1 DEPENDING ON THE SEVERITY OF THE LESION.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHROMOBLASTOMYCOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>WHEN NECESSARY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHROMOBLASTOMYCOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120704606</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>5G/250MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559459-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120705264</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>1 TABLET 5 TIMES A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 5 TIMES A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559460-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>220 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugbatchnumb>1027244</drugbatchnumb>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D                          /00944201/</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12                        /00056201/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STICKY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPPERTONE DRY OIL TANNING PUMP SPRAY SPF-10</medicinalproduct>
        <drugbatchnumb>1M03A3</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPPPERTONE SPORT CLEAR CONTINUOUS SPRAY SUNSCREEN SPF-50</medicinalproduct>
        <drugbatchnumb>1C4291</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MSD-1208FRA000151</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPPERTONE SENSITIVE SKIN FACES SPF-50</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559467-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2012SA052451</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DAILY IN MORNING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-AMGEN-ITACT2012041391</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20120600144</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugdosagetext>LAST TAKEN ON 20-MAY-2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>LAST TAKEN ON 20-MAY-2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>LAST TAKEN ON 20-MAY-2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ECSTASY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SUBSTANCE USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20120712620</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120713655</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712792</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559474-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20120705901</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>FREQUENCY: 1, INTERVAL:4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEUKAEMIA PLASMACYTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEUKAEMIA PLASMACYTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKAEMIA PLASMACYTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559475-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20120705915</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKAEMIA PLASMACYTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LEUKAEMIA PLASMACYTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugbatchnumb>2009-3-5</drugbatchnumb>
        <drugdosagetext>FREQUENCY:4, INTERVAL: 1</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LEUKAEMIA PLASMACYTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120302125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>FOR UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050718</drugauthorizationnumb>
        <drugdosagetext>FOR UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>FOR UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559477-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120302121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONATUMUMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2012SA047804</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>DOSE-NOT SPECIFIED, IT DEPENDS ON THE PATIENT'S GLUCOSE LEVELS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559480-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-MILLENNIUM PHARMACEUTICALS, INC.-2011-00477</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.42 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.06 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110114</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559481-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120302126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFED MEDICATIONS</medicinalproduct>
        <drugdosagetext>UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20120713358</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20120714761</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL GROWTH RESTRICTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugauthorizationnumb>017694</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>FOETAL EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559484-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>B000079910</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>B000079910</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>12438</drugbatchnumb>
        <drugadministrationroute>002</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>FOR 7 YEARS</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX GUM 2 MG ORIGINAL</medicinalproduct>
        <drugdosagetext>SINCE YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120705142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUTROGENA T/GEL THERAPEUTIC SHAMPOO ORIGINAL</medicinalproduct>
        <drugbatchnumb>3471L0481</drugbatchnumb>
        <drugdosagetext>ABOUT HALF A DOLLAR SIZE AMOUNT, ONCE ONLY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-JNJFOC-20120800162</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DORIBAX</medicinalproduct>
        <drugauthorizationnumb>022106</drugauthorizationnumb>
        <drugdosagetext>2 VIALS HAD BEEN ADMINISTERED TILL THE DATE OF REPORT</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PYELONEPHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>33069723</drugbatchnumb>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP011811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-MPIJNJ-2012-02502</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>18 MG/M2, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120130</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>58 MG/M2, UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120130</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>11 MG/M2, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120325</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SA-MPIJNJ-2012-04712</companynumb>
    <primarysource>
      <reportercountry>SAUDI ARABIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>8 DF, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-MILLENNIUM PHARMACEUTICALS, INC.-2012-02163</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2.45 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2012SA052815</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAZITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CABAZITAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>201023</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USACT2012045965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugbatchnumb>BX01554222</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>37.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>(BED TIME)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZTROPINE MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559496-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120512791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>119.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SEASONAL AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>BKB3L01</drugbatchnumb>
        <drugauthorizationnumb>22264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120706483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120714062</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120600446</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120712542</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERGROWTH BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCREAZE</medicinalproduct>
        <drugauthorizationnumb>022523</drugauthorizationnumb>
        <drugdosagetext>16000 UNITS LIPASE/WITH MEALS AND SNACKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19890101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>16800 UNITS LIPASE/ADJUST AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>022523</drugauthorizationnumb>
        <drugdosagetext>16800 UNITS LIPASE/ADJUSTED AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20120714332</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ID-JNJFOC-20120713169</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRADURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-JNJFOC-20120713564</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120713175</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugauthorizationnumb>85055</drugauthorizationnumb>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOZINE</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-091637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-075300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBUTAL</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-025618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>27 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>15 MG, TWICE A WEEK ON MONDAY AND FRIDAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKOCYTOCLASTIC VASCULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-007538</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091216</drugenddate>
        <drugtreatmentduration>251</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-042383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KELOID SCAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBETA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>R-TANNA [CHLORPHENAMINE TANNATE,PHENYLEPHRINE TANNATE]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080612</drugenddate>
        <drugtreatmentduration>1243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080612</drugenddate>
        <drugtreatmentduration>1243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559519-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-035630</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHAKUYAKUKANZOUTOU</medicinalproduct>
        <drugdosagetext>DAILY DOSE 7.5 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 400 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>DAILY DOSE 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>DAILY DOSE 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRACLID</medicinalproduct>
        <drugdosagetext>100000 U</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE 20 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugdosagetext>DAILY DOSE 12.45 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASTARON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>DAILY DOSE 24 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>DAILY DOSE 990 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN (HUMAN)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PORTOLAC</medicinalproduct>
        <drugdosagetext>DAILY DOSE 36 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-032822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOBILIARY SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MURPHY'S SIGN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>1 PILL, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-032428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.19</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>20 MG, QID, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>5/500 TABLET, 1-2 TABLETS, EVERY 4 TO 6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559522-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-032651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.342</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>100 IU, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FACTIVE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMRIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugdosagetext>37.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLI</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2011-047442</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>EOS103-008201</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROENDOCRINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110504</drugenddate>
        <drugtreatmentduration>1810</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5 MG TOTAL DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG PRN QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>STRENGTH: 10MG/5ML , DOSE:10 MG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>STRENGTH: 10MG/5ML, DOSE: 50-100 MG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>80 MG TOTAL DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DUODENAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WIND EZE</medicinalproduct>
        <drugdosagetext>125 MG PRN (TOTAL DAILY DOSE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERUCTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>EOS103-008201</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>^15 QDS^, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPPERMINT OIL</medicinalproduct>
        <drugdosagetext>1-2 CAPSULES PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>30-60 MG PRN (TOTAL DAILY DOSE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-032585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>92405A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>3 MG, HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugdosagetext>350 MG, QHS MAY USE UP TO TID PRN</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG, EVERY 8 HOURS AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugdosagetext>2 G, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5MG/500MG, 1 TO 2 TABLETS EVERY 4 TO 6 HOURS AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>400 MG, TID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SIGMOIDOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>400 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG, QHS PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>92682A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>AMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUSSIONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SIGMOIDOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559525-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-010971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-069238</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>800MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120103</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON [GLYCYRRHIZIC ACID]</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PORTOLAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERAMMONAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA DUE TO HEPATIC DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERATINAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ARTERIAL THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOALBUMINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012028620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRODUCT TRANSFUSION DEPENDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>20000 IU, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559528-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-065744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-014750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>? TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OVARIAN CYST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061124</drugenddate>
        <drugtreatmentduration>275</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111217</drugenddate>
        <drugtreatmentduration>350</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE W/ CODEINE</medicinalproduct>
        <drugdosagetext>6.25-10, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120421</drugenddate>
        <drugtreatmentduration>984</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-017460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>199.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>37.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080831</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559535-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-015112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.517</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugdosagetext>5/325, 1 TO 2 TABLETS Q4 PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>325/5, 1 TO 2 EVERY 4 HOURS PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>5 MG, 1 EVERY HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-021927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.365</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOLOGICAL TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090914</drugenddate>
        <drugtreatmentduration>309</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090914</drugenddate>
        <drugtreatmentduration>309</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>OCCASIONALLY AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>? TABLET AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559537-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-017445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.667</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>10 MG, BID,TAKE TWO TO THREE TABLETS TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBINUL FORTE</medicinalproduct>
        <drugdosagetext>1 MG, TWO TO THREE TIMES A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, Q4HR, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL/APAP/ULTRACET</medicinalproduct>
        <drugdosagetext>37.5/325 MG TAKE ONE OR TWO EVERY FOUR TO SIX HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SEBORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070716</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, TWELVW HOURS, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 MCG MONTHLY TIMES THREE, THEN DAILY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, UNK, ONE EVERY MORNING AND ONE EVERY EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/500 MG ONE OR TWO EVERY SIX HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MCG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, ONE EVERY 8 HOURS, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG, TAKE THREE EVERY MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTON PUMP INHIBITORS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559539-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-019830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>UNK U, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-053432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOLOGICAL TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLOX</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>2 PUFF(S), BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, 7 DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugdosagetext>2 SPRAYS, EVERY DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>40 MG, EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MCG, EVERY A.M.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugdosagetext>2 %, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120111</drugenddate>
        <drugtreatmentduration>2554</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>1 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MCG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>0.4 MG, EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugdosagetext>2 PUFF(S), Q4HR</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111125</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-055920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1-2 TABLETS EVERY 4-6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>90 MCG, 2 PUFFS AS NEEDED</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110414</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>500 MG,1 TABLET EVERY 6-8 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110414</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>500 MG,1 CAPSULE 3 TIMES A DAY FOR 10 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>1 OR 2 SPRAYS IN EACH NOSTRIL DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, 1 TABLET 2 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERTEC</medicinalproduct>
        <drugdosagetext>10 MG,1 DAILY</drugdosagetext>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 PILL DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, 1 TAB DAILY PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110414</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-014750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559544-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-070032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559545-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-022059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSVERSE SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
        <drugdosagetext>100 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20061202571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20120519341</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120707605</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>021444</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20090506672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>PATIENT WAS ON 3MG,4MG AND 5MG OF RISPERIDONE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>PATIENT WAS ON 200MG.300MG AND 400MG OF QUETIAPINE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>PATIENT WAS ON 3MG,4MG AND 5MG OF RISPERIDONE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>PATIENT WAS ON 200MG.300MG AND 400MG OF QUETIAPINE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>PATIENT WAS ON 3MG,4MG AND 5MG OF RISPERIDONE.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>PATIENT WAS ON 200MG.300MG AND 400MG OF QUETIAPINE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559550-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120714661</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351338USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559553-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA02912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANIMAL BITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090126</drugenddate>
        <drugtreatmentduration>185</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090126</drugenddate>
        <drugtreatmentduration>2218</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559554-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-350513ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>077470</drugauthorizationnumb>
        <drugdosagetext>5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-350071ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>61926</drugauthorizationnumb>
        <drugdosagetext>2 GRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-EU-03766GD</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugauthorizationnumb>012836</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16546BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16552BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALERS</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>N0110305970075-476,11C2204</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16557BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>A91970C</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559566-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>144.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-12P-008-0961627-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050662</drugauthorizationnumb>
        <drugindication>URINARY TRACT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>240 MG DAILY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXYCILLIN-POTASSIUM CLAVULANATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559570-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN007420</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUNOL (SODIUM GUALENATE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>44</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA052779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PSYCHOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20839</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugbatchnumb>AU001935</drugbatchnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>PSYCHOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559583-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA044139</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACUNAR INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DISOPYRAMIDE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACUNAR INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559585-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00B90</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>339</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559586-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559587-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2012-041905</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCOHERENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (11712)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO (11712)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>118749</drugbatchnumb>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>200 MG, QD (OD)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>350</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559588-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2010SE34107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>AGITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISCODYL</medicinalproduct>
        <drugdosagetext>5</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBUR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZIN</medicinalproduct>
        <drugdosagetext>25</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>250 TO 500 MG PO BID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NERVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>019129</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRIGEMINAL NERVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559591-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1013404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAXAGLIPTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAXAGLIPTIN</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugauthorizationnumb>090334</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugdosagetext>CHANGED Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>CHANGED Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559598-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1201USA03455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY OF PELVIS AND HIP ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED OESOPHAGEAL WEB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVISTA</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA043136</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEZAFIBRATE</medicinalproduct>
        <drugdosagetext>DOSE: 200</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>DOSE: 0.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DOSE: 20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHADOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>DOSE: 15</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugdosagetext>DOSE: 1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020496</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBRETID</medicinalproduct>
        <drugdosagetext>DOSE: 5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROGENIC BLADDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1011167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMERGENCY CONTRACEPTIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351441USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>T99127B1</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012028419</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>3 TO 4 CAPSULES, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012179671</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>11719</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012123410</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE/VALSARTAN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHIAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012152624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>42288</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012183655</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50734</drugauthorizationnumb>
        <drugdosagetext>22.56 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>188 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>188 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559617-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185792</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559618-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012155756</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN RDNA</medicinalproduct>
        <drugdosagetext>3.6 MG, WEEKLY</drugdosagetext>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559619-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012183269</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012174345</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120124</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012179778</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugdosagetext>HALT TABLET OF 2MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugbatchnumb>N6810</drugbatchnumb>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMIN /BRA/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559622-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012169692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT CONTAINER SEAL ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TAMPERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>UNK, (INCREASED TO TWO AND HALF TABLET OF 10MG BY SPLITTING TWO TIMES A DAY WHICH HE MENTIONED)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE/TOBRAMYCIN SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugbatchnumb>B120255</drugbatchnumb>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>25 MG, (10MG AT ONE TIME THEN 10MG AND THEN 5MG (HALF TABLET, TOTAL THREE TIMES A DAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRINZOLAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>UNK, (SINCE 10 YEARS TWO TABLETS OF 10MG DAILY)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>UNK, (FURTHER INCREASED TO THREE TABLETS)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012183946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.5 MG/DAY, 7 INJECTIONS/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE PHENYL PROPIONATE INJ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD LUTEINISING HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABERGOLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERPROLACTINAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE PHENYL PROPIONATE INJ</medicinalproduct>
        <drugindication>HYPOGONADISM MALE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE PHENYL PROPIONATE INJ</medicinalproduct>
        <drugindication>BLOOD FOLLICLE STIMULATING HORMONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CORTICOTROPHIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTHYRONE</medicinalproduct>
        <drugindication>PRIMARY HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELTHYRONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD THYROID STIMULATING HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012169712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.703</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT CONTAINER SEAL ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT PACKAGING ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRINZOLAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>TWO AND HALF TABLET OF 10MG BY SPLITTING, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugbatchnumb>B120255</drugbatchnumb>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>THREE TABLETS 10MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugbatchnumb>B120255</drugbatchnumb>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAPAZOLE</medicinalproduct>
        <drugauthorizationnumb>040320</drugauthorizationnumb>
        <drugdosagetext>TWO TABLETS 10MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE/TOBRAMYCIN SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559627-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN DURING A DAY.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION AND MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN DURING A DAY.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>20214</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN DURING A DAY.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559628-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559629-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>4 DF, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HONEY SPIRIT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-072865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>239121K</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559634-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMPRIN TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559638-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.773</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER RENTENTION MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugbatchnumb>NAA09DR</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559641-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559642-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>NAA00R5</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559643-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559644-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>BA8423A</drugbatchnumb>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-053444</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEYAZ</medicinalproduct>
        <drugauthorizationnumb>022532</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559646-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-055520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCLERAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030812</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>12.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC IMAGING PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>20 MG, OM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL SCAN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030807</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030812</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>4 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>10000 U, BIW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2012-075619</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MU-CRON [CEPHAEL SPP.,GUAIF,PARACET,PHENYLPROPANOLAM HCL]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugdosagetext>1 DF EVERY 12 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-072142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>129</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>6 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-068935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUGS FOR PEPTIC ULCER AND GORD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMENTARY TRACT AND METABOLISM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>BXFNGW1</drugbatchnumb>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE (1 TABLET AT NIGHT)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugdosagetext>400 MG, 8 A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL- AND TRIGLYCERIDE REDUCERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960729-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIDRADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIBICLENS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIDRADENITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0889047-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0963071-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>2 PACKETS A DAY</drugdosagetext>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961525-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOMA OF CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZD6244 HYDROGEN SULFATE</medicinalproduct>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947775-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYELOCALIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL MEGAURETER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022417</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0960207-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEHCET'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA NODOSUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956171-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLEFT LIP AND PALATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ABBOTT-12P-035-0959878-00</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928052-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959918-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION PATHOLOGICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPLIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPLIN</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>1 DAILY, NOT SURE OF DOSE</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>140762E</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559664-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA03339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD STING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESTROGEN DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULOSQUAMOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS PERENNIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>3873</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPY UNSPECIFIED</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPY UNSPECIFIED</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES (UNSPECIFIED)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>3380</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVENING PRIMROSE OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>2 %, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS                               /07357001/</medicinalproduct>
        <drugdosagetext>500 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4MG/5ML, MONTHLY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugdosagetext>2 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>325 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C                          /00008001/</medicinalproduct>
        <drugdosagetext>500 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>500 UG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZD6244 HYDROGEN SULFATE</medicinalproduct>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006435</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>613327</drugbatchnumb>
        <drugdosagetext>1000 MG/M2, OVER 30 MIN WEEKLY FOR WEEKS 1-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>718781</drugbatchnumb>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>613327</drugbatchnumb>
        <drugdosagetext>1000 MG/M2, OVER 30 MIN Q WEEK FOR WKS 1-3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>718781</drugbatchnumb>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006991</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006986</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559671-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006180</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP007002</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559673-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006990</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012US006556</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP007029</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006989</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2011US008635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugbatchnumb>1100238</drugbatchnumb>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111107</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugindication>URGE INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugindication>MICTURITION URGENCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006992</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>21518</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugbatchnumb>1100238</drugbatchnumb>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006995</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559682-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>200 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>180 UG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX                            /00754501/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559683-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006994</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559684-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP007027</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP006988</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
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        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
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        <drugstartdate>20120529</drugstartdate>
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      <drug>
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        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugindication>TRACHEAL CANCER</drugindication>
      </drug>
    </patient>
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  <safetyreport>
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      <reportercountry>CHINA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
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        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060614</drugstartdate>
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  <safetyreport>
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    <transmissiondateformat>102</transmissiondateformat>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
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        <drugindication>LIVER TRANSPLANT</drugindication>
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        <drugstartdate>20070121</drugstartdate>
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      <drug>
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        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>8559689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <companynumb>CN-ASTELLAS-2012JP006987</companynumb>
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      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
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  <safetyreport>
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      <reportercountry>CHINA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
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      <drug>
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        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
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      <reportercountry>CHINA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <patient>
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      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
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        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>8559692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
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        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
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        <drugindication>NON-SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
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        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    <safetyreportid>8559693-X</safetyreportid>
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    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
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    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060327</drugstartdate>
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    </patient>
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    <safetyreportid>8559694-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
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        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIVER TRANSPLANT</drugindication>
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    </patient>
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    <safetyreportid>8559696-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receiptdate>20120727</receiptdate>
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    <companynumb>CN-ASTELLAS-2012JP006979</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
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        <drugindication>LIVER TRANSPLANT</drugindication>
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        <drugstartdate>20071215</drugstartdate>
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    </patient>
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    <safetyreportid>8559697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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    <receiptdate>20120730</receiptdate>
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      <reportercountry>ITALY</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULSELESS ELECTRICAL ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEPATIC ISCHAEMIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
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        <medicinalproduct>NOREPINEPHRINE BITARTRATE</medicinalproduct>
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        <medicinalproduct>DOMPERIDON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
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        <drugindication>PROPHYLAXIS</drugindication>
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        <medicinalproduct>RIFAXIMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
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        <drugdosagetext>UNK</drugdosagetext>
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        <drugdosagetext>UNK</drugdosagetext>
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        <medicinalproduct>SELECTIVE SEROTONIN REUPTAKE INHIBITORS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
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        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110731</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPRENALIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110731</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>MK850</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559699-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120707964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559700-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559701-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559708-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012182208</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>370 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559709-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559711-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012182157</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY(CURES OF 4 WEEKS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559713-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011316078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559714-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012178860</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN  AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESIDRIX</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559717-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012164457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559718-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2012185325</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>FORMICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559719-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>890707</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>0.3/1.5 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559721-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>B10427430</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559722-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012147539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugauthorizationnumb>087059</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559723-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559724-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugbatchnumb>C88094</drugbatchnumb>
        <drugauthorizationnumb>075209</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559725-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559726-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012169680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.132</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT DROPPER ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugbatchnumb>Z01318</drugbatchnumb>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559727-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012181131</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSIL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>91062</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TONSIL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559728-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012185747</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRIAPISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559729-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559730-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.771</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>MENOPAUSAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559731-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559732-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559733-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRING</medicinalproduct>
        <drugauthorizationnumb>020472</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559734-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011189550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SUL HYT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SCOLIOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559735-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>0.15 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559736-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559737-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559738-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012185663</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOUR BLINDNESS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>25 MG, ONCE AT NIGHT</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO USER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1 MG ONCE AT NIGHT</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>WITHDRAWAL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012180824</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>20402</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN JAW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN JAW</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559740-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.878</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, DAILY</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559741-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.365</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559742-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012180836</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>SUPERINFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugindication>SUPERINFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>SUPERINFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>1 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559744-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012116978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>F75237</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559745-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.585</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073542</drugauthorizationnumb>
        <drugdosagetext>25MG TABLET SPLIT INTO A HALF</drugdosagetext>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>073542</drugauthorizationnumb>
        <drugdosagetext>SPLITTING 25 MG TABLET INTO A ONE QUARTER, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559746-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012127253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 5X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCTURA XR</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V112292</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V112292</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>100 UG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1 G, 4X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>135 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559747-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ENTEROCOCCAL BACTERAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559748-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.351</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>UNK (ONE SPRAY), DAILY</drugdosagetext>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559750-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY, (DAILY)</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559751-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-BAYER-2012-077008</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE/DIENOGEST</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559753-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012185482</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559754-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559755-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>21938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559756-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012112903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>50/75 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>C10015830</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559757-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559758-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 4X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559759-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559760-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012106150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559761-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012182680</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559763-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559764-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559766-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-PFIZER INC-2012183777</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021267</drugauthorizationnumb>
        <drugindication>ASPERGILLOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559767-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012184375</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLTUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>5110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559768-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.98</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012183469</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN TEST NEGATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugauthorizationnumb>050750</drugauthorizationnumb>
        <drugdosagetext>1 DF, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ABSCESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559770-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559771-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012070893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559772-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559773-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012167526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.796</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-CLOF-1002178</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPULMONARY ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMSACRINE</medicinalproduct>
        <drugdosagetext>225 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugdosagetext>225 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>A453096</drugbatchnumb>
        <drugauthorizationnumb>21673</drugauthorizationnumb>
        <drugdosagetext>19 MG, QD; DAY 1 TO 5; CYCLES I AND II</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>3000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>1900 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>3000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559775-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.063</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559777-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559778-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012138707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugbatchnumb>F5432S</drugbatchnumb>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559779-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.202</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugauthorizationnumb>21266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559780-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012185656</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559781-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012184409</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYP COLORECTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugauthorizationnumb>012151</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559782-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559783-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.773</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012170643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, (FREQUENCY UNKNOWN)</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559785-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182943</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>75 UG, DAILY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>F76553</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559788-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012174431</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugbatchnumb>1271110</drugbatchnumb>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>RENAL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012184485</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugauthorizationnumb>019668</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559790-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559791-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012180711</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559792-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012140845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>163</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>ANGER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>ANGER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>ANGER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>ANGER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugbatchnumb>V120657</drugbatchnumb>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559793-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012152650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MERALGIA PARAESTHETICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559794-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559795-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559796-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>F53342</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559797-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012179517</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYMAD</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN D DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSLIF BREEZHALER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLENIO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559799-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559800-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012165969</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL COLD AND SINUS</medicinalproduct>
        <drugbatchnumb>F80897</drugbatchnumb>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL COLD AND SINUS</medicinalproduct>
        <drugauthorizationnumb>019771</drugauthorizationnumb>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559801-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559803-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.967</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, FIRST 42 DAY CYCLE</drugdosagetext>
        <drugindication>RENAL CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559804-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559805-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559806-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012182270</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
        <drugtreatmentduration>235</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559807-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559808-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559809-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>2 CAPLETS OF 200 MG TOGETHER ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559810-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559811-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012052345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080826</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugbatchnumb>C0148</drugbatchnumb>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugindication>INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>137 UG, DAILY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>2 TABLETS DAILY IN THE MORNING</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559813-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2012181437</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY (1-0-0)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugindication>CARDIAC FLUTTER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559814-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.506</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTISOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559815-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559816-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559817-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011145159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING MONTH PACK AND CONTINUING MONTH PACKS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE W/ CODEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559818-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>C120551</drugbatchnumb>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>HALF OF 1MG TABLET AT BED TIME DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559819-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559820-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184489</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184518</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559822-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.132</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A10473430</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A10473430</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-PFIZER INC-2012184677</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugdosagetext>3 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>91063</drugauthorizationnumb>
        <drugdosagetext>600 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>110 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101022</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN-125</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAFLO</medicinalproduct>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559827-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012179691</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSOPHARYNGEAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>2X/DAY, 12 IN 12 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugauthorizationnumb>050670</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559829-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.853</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559830-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012181430</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCHISTOSOMIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MANSIL</medicinalproduct>
        <drugauthorizationnumb>18069</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHISTOSOMIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012144198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SUL HYT</medicinalproduct>
        <drugauthorizationnumb>18565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SUL HYT</medicinalproduct>
        <drugauthorizationnumb>018565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110610</drugenddate>
        <drugtreatmentduration>207</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>300-30 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16541BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559833-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16539BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559834-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202950</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 300</medicinalproduct>
        <drugbatchnumb>11L2665U</drugbatchnumb>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>95 ML, SINGLE, FLOW RATE: 5 ML/SEC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COMPUTERISED TOMOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559835-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202683</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIRAY 160</medicinalproduct>
        <drugbatchnumb>11I975</drugbatchnumb>
        <drugauthorizationnumb>019710</drugauthorizationnumb>
        <drugdosagetext>100 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>30 ML, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559836-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008906</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUNOL GARGLE LIQUID</medicinalproduct>
        <drugadministrationroute>049</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE:OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559839-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202961</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 GTT, DAILY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL</medicinalproduct>
        <drugdosagetext>1 GTT, DAILY</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559841-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559842-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559843-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-EISAI INC-E7389-02121-CLI-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120210</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559844-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>89160</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559845-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>078273</drugauthorizationnumb>
        <drugdosagetext>3 MG IM Q3 HOURS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>078273</drugauthorizationnumb>
        <drugdosagetext>3 MG IV Q4 HOURS PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN LOWER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE/ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/325 MG UP TO 4 TABLETS QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202903</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202960</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202860</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202906</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENNSAID</medicinalproduct>
        <drugauthorizationnumb>020947</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202904</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559851-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202873</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENNSAID</medicinalproduct>
        <drugauthorizationnumb>020947</drugauthorizationnumb>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JOINT INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1700 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
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    </patient>
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  <safetyreport>
    <safetyreportid>8559852-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202905</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>8559853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202959</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559854-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
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    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008972</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
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        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELPINAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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      <drug>
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        <medicinalproduct>FEBURIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
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        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
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    <safetyreportid>8559855-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-JNJFOC-20120713710</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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  <safetyreport>
    <safetyreportid>8559856-3</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712846</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36.29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
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        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
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    </patient>
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  <safetyreport>
    <safetyreportid>8559857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20111110031</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>46.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GROWTH HORMONE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090403</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110531</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110630</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>8559858-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20110510322</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080617</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>8559859-9</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
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    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202969</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
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    <safetyreportid>8559860-5</safetyreportid>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
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    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <drug>
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        <drugdosagetext>UNK</drugdosagetext>
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    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202970</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202968</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202963</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM IODIDE I 131</medicinalproduct>
        <drugauthorizationnumb>016515</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RADIOACTIVE IODINE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-PFIZER INC-2012185857</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-2012186526</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012186649</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559873-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.447</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559874-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.202</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTRAZENECA-2012SE51455</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28447</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>55.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
        <drugauthorizationnumb>020498</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG TWICE A DAY + 2X300MG AT NIGHT</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012186253</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTHIADEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTHIADEN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.224</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559884-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0961567-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>WEDNESDAYS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugdosagetext>100 MCH INH</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0938938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTICOAGULANT THERAPY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559886-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961249-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRALAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559887-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0962635-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU009KW</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>107</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2011-099252</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REZALTAS</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111124</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRIPLATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 120 MG</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110525</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>330 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111106</drugenddate>
        <drugtreatmentduration>117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110712</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>10 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559890-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAYER-2012-077051</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPEROXALURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYSTAL NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM + SULFAMETHOXAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREON [AMYLASE,LIPASE,PANCREATIN,PROTEASE]</medicinalproduct>
        <drugindication>PANCREATIC INSUFFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>21085</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANCICLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIKACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-000670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACTERIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-21880-11051154</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUBCLAVIAN STEAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10+5+5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100304</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559894-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.853</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugbatchnumb>A81294M</drugbatchnumb>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559895-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2012040263</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>500 MUG, 2 INJECTIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559897-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTRANS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>10 MCG, Q1H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 MG, SEE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OTICUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugbatchnumb>A81294Q</drugbatchnumb>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugindication>MYELOID METAPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559901-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU061373</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012DE010583</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>CONFUSIONAL STATE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BGJ398</medicinalproduct>
        <drugdosagetext>125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>SEDATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004051</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559905-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012KR065964</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559907-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugbatchnumb>F0010</drugbatchnumb>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLAIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559908-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU045905</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559909-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011US55738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>360 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILVER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DCN-WO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559910-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE066036</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, ONE TABLET IN THE MORNING AND ONE IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559911-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB064943</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESCOL XL</medicinalproduct>
        <drugauthorizationnumb>021192</drugauthorizationnumb>
        <drugdosagetext>80 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012ES065860</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU051244</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERPIGMENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugdosagetext>ALTERNATING 300 MG AND 350 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NODULAR VASCULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559915-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA061990</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ENZYMES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559916-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA047819</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559917-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR010116</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRILON</medicinalproduct>
        <drugindication>CHONDROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>150 MG, ONCE MONTHLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVACOR</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>BLOOD VISCOSITY INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugbatchnumb>S1169</drugbatchnumb>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAMIFIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559918-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 DF (160 MG), DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559919-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>620 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559920-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US04542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAPUBIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>90 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>500 MG, THREE TABLETS BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMAXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INAPSINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>4 MILLIGRAMS TWO TO THREE TIMES PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, PRN,Q6H</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559921-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN063706</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugauthorizationnumb>017808</drugauthorizationnumb>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANWU</medicinalproduct>
        <drugdosagetext>5 G, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>016608</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559923-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>50 MG, Q12H</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2012SE52578</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>16/12,5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004133</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>375 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559926-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012183915</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>20/12.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-PFIZER INC-2012185478</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VENA CAVA THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugdosagetext>2350 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559929-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012181087</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugdosagetext>720 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugdosagetext>960 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012185400</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559931-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUTRANS</medicinalproduct>
        <drugbatchnumb>71201B3A</drugbatchnumb>
        <drugauthorizationnumb>021306</drugauthorizationnumb>
        <drugdosagetext>10 MCG/HR, WEEKLY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012185781</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HELICOBACTER GASTRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHTHERIA TOX/PERTUSSIS VACC/POLIOMYELITIS VACCINE INACT/TETANUS TOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185433</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>20 MG/ 12.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559935-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBILVO</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugauthorizationnumb>020796</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINSULOSIA</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NL066247</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TERMINAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML ONCE PER 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML ONCE PER 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0038</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100 ML ONCE PER 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US14844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA AREATA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTEROVAGINAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSPIRATORY CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROXYSMAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DUCT DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>500 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 DF, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLOPHINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
        <drugdosagetext>40000 U, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD TRANSFUSION, AUXILIARY PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLMETHACRYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559938-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US15259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYASTHENIA GRAVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGO-CRIMEAN HAEMORRHAGIC FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PULP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL SECRETION RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRAPYRAMIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUDWIG ANGINA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG CONSOLIDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONNECTIVE TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX                                /DEN/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHILUS ^ZYMA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN EXPECTORANT W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRESOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNISOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU0064H</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-014734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.143</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559941-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-070312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ODOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>516</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559942-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-052357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.771</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559943-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559944-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559945-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-033098</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, 1 A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 MG, Q4HR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugdosagetext>30 MG, 1-2 EVERY 4-6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTEREN HCT</medicinalproduct>
        <drugdosagetext>75-50MG, 1 EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>DYSFUNCTIONAL UTERINE BLEEDING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559946-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-093369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>2 PUFF(S), ONLY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>50MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>84579A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
        <drugtreatmentduration>58</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 UNITS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50MCG ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBITUSSIN DM</medicinalproduct>
        <drugdosagetext>AS INSTRUCTED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>AS INSTRUCTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugdosagetext>AS INSTRUCTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559947-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-349814USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>21998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESTIMATE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120624</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TWO TABLET MORNING AFTER PILL</medicinalproduct>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559948-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-NOVOPROD-355251</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559949-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-NOVOPROD-356897</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN RT</medicinalproduct>
        <drugbatchnumb>BU60391</drugbatchnumb>
        <drugdosagetext>36 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FACTOR VIII DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOSEVEN RT</medicinalproduct>
        <drugbatchnumb>BU60391</drugbatchnumb>
        <drugdosagetext>24 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559950-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-356612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugbatchnumb>BZF0178</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559951-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-351894</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020741</drugauthorizationnumb>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METBAY</medicinalproduct>
        <drugdosagetext>2500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120208</drugenddate>
        <drugtreatmentduration>470</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-NOVOPROD-356626</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOW BIRTH WEIGHT BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID FLEXPEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-352896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2MG QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-356970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL                          /00045402/</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7032740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CAROTID ARTERY DISSECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003459</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003459</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-JNJFOC-20120800212</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugdosagetext>1 DF AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559958-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOPEDIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559960-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120800041</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712431</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7093696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559963-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7147841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002717</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559964-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7145462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559965-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559966-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011024</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS TRANSIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559967-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011046</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080320</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1109USA02510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE WART</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR MICROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLOASMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070201</drugenddate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1102USA01702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERUMEN IMPACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70/2800</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080611</drugenddate>
        <drugtreatmentduration>788</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100228</drugenddate>
        <drugtreatmentduration>515</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7031031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugindication>BLADDER DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559972-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7048690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-231553K08USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED HYPOGLYCEMICS MEDICATION</medicinalproduct>
        <drugindication>HYPOGLYCAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7113765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU0002502</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU0002502</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12071994</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY GASTROINTESTINAL TRACT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559976-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7026614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16753584</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA-BM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4MG: 4JUN-11JUN12(8DAYS) 2MG:12JUN-29JUN12(18DAYS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTOMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-16801755</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugdosagetext>ZIAGEN '300MG TAB'</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>INTERRUPTED ON 20JUN12 COUMADIN TABS 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugdosagetext>VIREAD '245MG TAB'</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012117229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.796</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>3 MG, 1X/DAY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559980-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559981-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012177465</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559982-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012082841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070531</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559983-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012179037</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>050608</drugauthorizationnumb>
        <drugdosagetext>1.5 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATABON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORIPENEM MONOHYDRATE</medicinalproduct>
        <drugdosagetext>0.25</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOLVON</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENALIN IN OIL INJ</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012170419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>UNK (TWO TABLETS ),DAILY</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>137 UG, DAILY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugindication>INCONTINENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012163473</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugbatchnumb>11515501</drugbatchnumb>
        <drugauthorizationnumb>050608</drugauthorizationnumb>
        <drugdosagetext>4.5 G, TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011298556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULAR PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugbatchnumb>1262051</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111031</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugbatchnumb>V1111460</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugbatchnumb>0970111</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158181</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012151100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>600 MG, EVERY 4 HRS</drugdosagetext>
        <drugindication>SCIATIC NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>10/325MG, TWO TABLET FOUR TIMES A DAY</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>20998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>750 MG, AS NEEDED</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559989-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012106067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559990-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012153865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.238</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559991-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012159606</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSCALCULIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGRESSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020882</drugauthorizationnumb>
        <drugdosagetext>1000MG:(400MG X 2 + 200MG X 1) DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENDON</medicinalproduct>
        <drugdosagetext>22.5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>90 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>350 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>0.8 G/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>300 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559992-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JO-SANOFI-AVENTIS-2012SA042180</companynumb>
    <primarysource>
      <reportercountry>JORDAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>DOSE: PCA (PATIENT CONTROLLED ANALGESIA)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559993-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012175974</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559994-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012177457</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559995-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012052397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559996-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012149046</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTRIL</medicinalproduct>
        <drugauthorizationnumb>008697</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559997-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012175904</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERONON R</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559998-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012052348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PAK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>MONTHLY MAINTENANCE PACK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8559999-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012052260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560000-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012175579</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>021719</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATHYMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560001-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-50794-12050784</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOMONOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDROXYUREA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SPLENOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDROXYUREA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>THRID OF INITIAL DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RH-EPO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090804</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LEUKOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SPLENOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560002-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012148454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V111323</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560003-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP028367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREGNYL</medicinalproduct>
        <drugbatchnumb>2CO9601</drugbatchnumb>
        <drugauthorizationnumb>017692</drugauthorizationnumb>
        <drugdosagetext>5000 IU, UNK</drugdosagetext>
        <drugindication>OVULATION INDUCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560004-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158193</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560005-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012118158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560006-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158151</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>[AMLODIPINE BESILATE 5 MG/ ATORVASTATIN CALCIUM 40 MG], UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>[AMLODIPINE BESILATE 5 MG/ ATORVASTATIN CALCIUM 40 MG], UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560007-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012150404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUTRITIONAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560008-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012147915</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>36.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GANATON</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>17.5 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOSOMATIC DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugdosagetext>4 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugdosagetext>1 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA CRYPTOCOCCAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FOLATE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560009-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-BAYER-2012-052665</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOHEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560010-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-AVENTIS-2012SA052228</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BICARBONATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PH INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PCO2 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugdosagetext>TAKING SEVERAL TABLETS PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMETEROL</medicinalproduct>
        <drugdosagetext>INHALATION</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIQUORICE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAILY DOSE: APPROXIMATELY 300 G</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560013-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>15 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560014-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2011042330</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTRALISING ANTIBODIES POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-ERYTHROPOIETIN ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFRACTORY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15 ML, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-THYROXINE                        /00068001/</medicinalproduct>
        <drugdosagetext>0.15 NG, QD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>10 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>150 MUG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>100 G, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>80 G, QD</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 G, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
        <drugdosagetext>15 G, 2 TIMES/WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2.5 G, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCONORM                          /00082702/</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 G, QD</drugdosagetext>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROFERRIN</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>300 G, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>500 G, QD</drugdosagetext>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560015-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE53812</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>20639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALDOXAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560016-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012016206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560017-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012066696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V120030</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560018-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012174337</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL STROMAL TUMOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560019-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012177681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560020-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012143988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560021-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012161011</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugindication>VESICOURETERIC REFLUX</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DWARFISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560022-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560023-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012077580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.03</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>JOINT SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560024-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012162798</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>19839</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560025-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012160444</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560026-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158328</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SENILE DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560027-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560028-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012168632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>010402</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560029-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012158340</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560030-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012136141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560031-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012140417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560032-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012144908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugauthorizationnumb>018422</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560033-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100829</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560034-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CERZ-1002563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>19.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>60 U/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560038-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAFYRAL</medicinalproduct>
        <drugauthorizationnumb>022574</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560039-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAFYRAL</medicinalproduct>
        <drugauthorizationnumb>022574</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560040-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAFYRAL</medicinalproduct>
        <drugauthorizationnumb>022574</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560041-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934681-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560042-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ABBOTT-12P-090-0919179-00</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560043-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0958089-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INTESTINAL FISTULA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560044-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ABBOTT-12P-066-0952503-00</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOUSE DUST ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560045-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0950227-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560046-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ABBOTT-12P-217-0960214-00</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>23 NOV, 7 DEC 2011- NOT APLICATED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560047-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958378-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560048-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952247-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PAPULE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DRY SKIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560049-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0915693-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>ONE AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL D3</medicinalproduct>
        <drugdosagetext>1-1 DAYS OD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>ONE TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugdosagetext>BD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTIMALARIAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLENIL 100</medicinalproduct>
        <drugdosagetext>BD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560053-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560054-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORGESTIMATE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugindication>OVARIAN CYST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING MONTH PACK, CONTINUING MONTH PACK WITH REFILLS</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560055-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012168074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, 2X/DAY</drugdosagetext>
        <drugindication>BRAIN NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, CYCLE FOR 42 DAYS  (DAILY)</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO LUNG</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-Q-10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>3.25 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560056-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560057-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560058-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009134</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560067-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009735</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560068-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009633</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSPANON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560069-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560070-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560071-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010001</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REPTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560072-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010236</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAVITAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560073-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-11P-062-0879645-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560074-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0960775-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOE AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560075-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960844-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560076-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0962040-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560077-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960365-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAEVUS FLAMMEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022417</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560078-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936246-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560079-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2010SP004036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GONORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560080-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-CELGENEUS-114-21880-12072280</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560085-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560087-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560088-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560089-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16537BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugdosagetext>24 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560090-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17038BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560091-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-12799BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201409A,11C3215</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560092-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-CELGENEUS-008-21880-12070508</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SENNA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560093-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE52226</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>767</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYLOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560102-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE36558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560103-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560104-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2012SE52136</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560105-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-12072466</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugdosagetext>400 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugdosagetext>1.5 GRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560106-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560107-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-GRCSP2011033336</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUTANEOUS SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560108-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE36545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>1202</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>798</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560109-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2012SA054242</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560110-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010611</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560111-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2011SA075466</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>6 TABLETS OF 500 MG EACH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugdosagetext>14 TABLETS OF 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>14 TABLETS OF 10 MG EACH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MOSAPRIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>14 TABLETS OF 50 MG EACH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560117-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-FRI-1000037517</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>LATTERLY IN HIGH DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>LATTERLY IN HIGH DOSES</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560118-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA050381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>EVERY MORNING AT 7:30</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560119-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-CELGENEUS-008-21880-12072242</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560121-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-075227</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560122-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-045573</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE DEPLETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KRYON</medicinalproduct>
        <drugdosagetext>UNKNOWN DOASAGE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560123-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-C5013-12050609</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEBACEOUS CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARCINOMA IN SITU OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111208</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>5.7143 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>160 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>5.7143 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>160 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081016</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560124-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>NOT SPECIFIED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560125-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugbatchnumb>G108529B</drugbatchnumb>
        <drugdosagetext>40000 IU, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HAEMOGLOBIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560126-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960365-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAEVUS FLAMMEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022417</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560127-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960000-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SHOCK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>INITIAL DOSE OF 80MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTION</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560136-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
        <drugdosagetext>600 MICROGRAM, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>2.857 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560137-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560138-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1103USA00910</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOBAR PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROADENOMA OF BREAST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100718</drugenddate>
        <drugtreatmentduration>536</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugindication>EX-TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugindication>EX-TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>556</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>300-1500</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTIROXINA S.O</medicinalproduct>
        <drugdosagetext>TO PRESENT</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>200 MG, HS</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50-175</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090105</drugenddate>
        <drugtreatmentduration>309</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560140-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-337313USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560141-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-SANOFI-AVENTIS-2012SA052411</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERSONALITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560142-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA052673</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID /SCH/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560143-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA053782</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPEUTIC RADIOPHARMACEUTICALS</medicinalproduct>
        <drugdosagetext>DOSE: 30 GY EACH TO LUMBAR VERTEBRA AND DORSAL VERTEBRA.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110729</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560144-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351401USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugdosagetext>QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SOMNOLENCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560145-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>4400 IU, 3 TIMES/WK</drugdosagetext>
        <drugindication>DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560147-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012173720</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560148-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-MSD-1207MYS009164</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMUSCULAR BLOCK PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECURRENCE OF NEUROMUSCULAR BLOCKADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>0.03 MG, ONCE</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>40 MG, ONCE</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>10 MICROGRAM, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUGAMMADEX SODIUM</medicinalproduct>
        <drugbatchnumb>136242</drugbatchnumb>
        <drugauthorizationnumb>022225</drugauthorizationnumb>
        <drugdosagetext>6 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NEUROMUSCULAR BLOCKADE REVERSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560153-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560154-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560155-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-006408</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.145</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIRSUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL</medicinalproduct>
        <drugdosagetext>0.75 MG, UNK</drugdosagetext>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110330</drugenddate>
        <drugtreatmentduration>1197</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCEPTROL</medicinalproduct>
        <drugdosagetext>4 %, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560156-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560157-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00D19</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560159-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-061312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENSTRUAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>342</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPNOTICS AND SEDATIVES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SEDATIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560160-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-003626</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINDAVATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZUNOL 5 P</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EKSALB</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMARARL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION OD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KINDAVATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULMETA: OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONA</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560161-X</safetyreportid>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CELGENEUS-144-21880-12070653</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER TRANSITIONAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>21880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560162-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2012SA052998</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>19908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560163-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE37903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560168-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1108USA01228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPOROMANDIBULAR JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL DISEASE CARRIER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DISPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH IMPACTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080122</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080903</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560170-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-FRI-1000037522</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POTENTIATING DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>021323</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>021323</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560171-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-ENDC20120043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE AND ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>040434</drugauthorizationnumb>
        <drugdosagetext>10/325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE/ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>040303</drugauthorizationnumb>
        <drugdosagetext>10/325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560172-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120612</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-TRIP20110127</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY ON ORAL CONTRACEPTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORGESTIMATE/ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>076335</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560173-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2012SE52295</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560174-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560175-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA053043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETIT MAL EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560176-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP034486</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>START AND STOP DATE : UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>START AND STOP DATE : UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.8MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugdosagetext>START AND STOP DATE : UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>START AND STOP DATE : UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560177-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA04581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEGENERATION OF UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081230</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080420</drugenddate>
        <drugtreatmentduration>1553</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL-HFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AEROBID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560180-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010985</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560181-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED OTHER MEDICATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560182-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2012SA053273</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560189-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16037BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560190-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14523BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201409A,11C1126</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugindication>TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201409A,11C1126</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560191-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CS-01082RP</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAJENTA</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560193-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560194-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-12072444</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560195-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>HMLX78</drugbatchnumb>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560196-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA008810</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SICKLE CELL ANAEMIA WITH CRISIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugauthorizationnumb>014215</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560197-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugauthorizationnumb>022277</drugauthorizationnumb>
        <drugdosagetext>140 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560198-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugdosagetext>NASAL SPRAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugindication>EYE PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugindication>EYE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560199-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL PLACENTAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560200-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARAFFIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560201-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1006USA00660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMA PROTEIN METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560202-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL PLACENTAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560203-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072209</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560204-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560205-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1090501</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560206-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1090545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560207-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560208-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1023500</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560209-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1049491</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY MASS INDEX DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>13263</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560210-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012185767</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NATRIURETIC PEPTIDE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560211-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012169215</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugauthorizationnumb>65421</drugauthorizationnumb>
        <drugdosagetext>10 MG/KG/DAY</drugdosagetext>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugdosagetext>30 MG/KG/DAY</drugdosagetext>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>5 MG/KG/DAY</drugdosagetext>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560212-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560213-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012183004</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugindication>INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560214-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560215-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012185634</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITODRINE HCL</medicinalproduct>
        <drugindication>LONG QT SYNDROME CONGENITAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITODRINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BRADYCARDIA FOETAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560216-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560217-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012185816</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560218-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012163343</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE</medicinalproduct>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560219-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1050006</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RETINAL VASCULAR THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560220-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012182312</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESILATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>2027</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>2027</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560221-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012185839</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEROSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560222-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560223-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-PFIZER INC-2012183304</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CAVERJECT</medicinalproduct>
        <drugdosagetext>7 UG, EVERY 3 DAYS</drugdosagetext>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560224-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1071513</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>7040 MAINTENANCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560225-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISSOCIATIVE IDENTITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugindication>DISSOCIATIVE IDENTITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560226-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012163810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50670</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560227-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012127337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN COUGH AND CHEST CONGESTION DM</medicinalproduct>
        <drugdosagetext>5-10 CC, QID, PRN, TOOK ONLY ONE DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN COUGH AND CHEST CONGESTION DM</medicinalproduct>
        <drugbatchnumb>3-0031-8736-12-8</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>UPPER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTEPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560228-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012154292</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.4 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>2 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.4 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIPERIDEN HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>2 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560229-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012183415</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELLP SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560230-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>019885</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560231-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1000881</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560232-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1058622</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INNOVAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560233-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012184859</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100130</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560234-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-2012SP020895</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOCEPREVIR</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>80 ?G, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560235-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1061225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIRECTAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560236-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1061185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560237-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-039773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>220 MG, TID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>1 TO 2 TABLETS Q HS, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>2 PUFF(S), DAILY PRN</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>10 MG/500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>2 MG, Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090506</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560238-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-028629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ACNE PREPARATIONS</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIMIGRAINE PREPARATIONS</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEYAZ</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WOMEN'S VITAMINS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560239-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090330</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN [ACETYLSALICYLIC ACID,CAFFEINE,PARACETAMOL,SALICYLAMIDE]</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560240-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1082781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>REDUCED DOSAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>REDUCED DOSAGE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RO 5466731 (HCV NS5B INHIBITOR)</medicinalproduct>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560241-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1067092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMAGNESAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC=6 IV ON DAY 1 (CYCLE 1-6)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>OVER 30-90 MINUTES ON DAY 1 OF CYCLES 2+. DRUG WITHDRAWN.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>OVER 3 HOURS ON DAY 1 (CYCLES, 1-6).</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN EPITHELIAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560243-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1084865</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALODONT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE 18/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE 18/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN ELIXIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560244-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-SANOFI-AVENTIS-200919863GDDC</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL BLOOD GLUCOSE LOWERING DRUGS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPROSARTAN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560245-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1031736</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE STIMULATION TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560246-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1050366</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>10/25 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDINE</medicinalproduct>
        <drugdosagetext>DRUG NAME: TILIDIN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugbatchnumb>1101789</drugbatchnumb>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 13/MAR/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560247-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1085418</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN L</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARENOXACIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560252-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1081092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECTIBIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B63061,B60181</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560253-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>INITIAL INFORMATION FOR THIS NON-INTERVENTIONAL STUDY/PROGRAM CASE, AER NUMBER 1095916, WAS RECEIVED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560254-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CYTOMEGALOVIRUS INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560255-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0961596-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>(MAX QDS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugdosagetext>BD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>EVERY OTHER WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANDO K</medicinalproduct>
        <drugdosagetext>BD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560256-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-12P-020-0961617-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FISTULA DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR PERSONAL HYGIENE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>4 INJECTIONS AT THE SAME DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 INJECTIONS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560257-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-062772</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCLONIC EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugdosagetext>650 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugdosagetext>650 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>DAILY DOSE:10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugdosagetext>500 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560258-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961367-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LOADING DOSE ONLY</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560259-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-12P-153-0962885-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560260-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ROCHE-1094741</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021858</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560261-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050758</drugauthorizationnumb>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560262-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ROCHE-1093725</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC CIRRHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560263-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560265-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-SANOFI-AVENTIS-2012SA045969</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560266-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-1093445</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560267-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-1090900</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>METASTASES TO KIDNEY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>METASTASES TO LUNG</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSE: 500 MG 4+3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560268-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1083308</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>20896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560269-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ID-ROCHE-1094694</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560270-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011324</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560271-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA02453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STIFF PERSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONNECTIVE TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THORACIC VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNCTIONAL GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS PYROPHOSPHATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROGENIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001215</drugenddate>
        <drugtreatmentduration>1811</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560272-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011088</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.41G/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEROFF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENILENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER (DIFLUPREDNATE)</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELTEPNON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560273-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HK-SANOFI-AVENTIS-2012SA045969</companynumb>
    <primarysource>
      <reportercountry>HONG KONG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560274-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SP-2012-07305</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMMUCYST</medicinalproduct>
        <drugbatchnumb>LOT NOT REP</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560275-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1082764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPORAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM NOS/MAGNESIUM NOS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560282-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1093813</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOBLASTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560283-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-SWECT2012039846</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>1 ML, QMO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KALCIPOS-D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560284-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1092780</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE PROMYELOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560285-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560286-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560287-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560288-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076553</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560289-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560290-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560291-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560292-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SP-2011-07619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOVINE TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERACYS</medicinalproduct>
        <drugbatchnumb>C3702A</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugindication>BLADDER CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERACYS</medicinalproduct>
        <drugbatchnumb>C3344A</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THERACYS</medicinalproduct>
        <drugbatchnumb>C3413A</drugbatchnumb>
        <drugadministrationroute>043</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560293-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1091643</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110619</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TMC435 (NS3/4A PROTEASE INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560294-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094508</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560295-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>461036</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560296-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201206007518</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560297-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR201207006036</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560298-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ELI_LILLY_AND_COMPANY-AT201207006177</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560299-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ELI_LILLY_AND_COMPANY-PT201207006181</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560300-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILETIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A927474C</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>70 U, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>245 U, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A877224A</drugbatchnumb>
        <drugdosagetext>15 U, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>220 U, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560301-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE LABOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GESTATIONAL DIABETES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>20 U, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS                  /01549301/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A955669A</drugbatchnumb>
        <drugdosagetext>16 U, EACH EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>16 U, EACH MORNING</drugdosagetext>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A840119A</drugbatchnumb>
        <drugdosagetext>32 U, EACH MORNING</drugdosagetext>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560302-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ELI_LILLY_AND_COMPANY-IE201207005947</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60MG, DAILLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560303-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201109001513</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPOSURE DURING BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELLP SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAMET</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110308</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDIEL</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110905</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOODMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110322</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110905</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>1.2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>345</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPAZON</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110905</drugenddate>
        <drugtreatmentduration>925</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560304-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201204001484</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560305-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207003168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IN-STENT CORONARY ARTERY RESTENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560306-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201204009957</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560307-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207006585</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560308-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ELI_LILLY_AND_COMPANY-BE201207006286</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>405 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560310-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207005721</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560311-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201206006276</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560312-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560313-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVERSION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560314-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201207006362</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560315-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA201207006452</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DELIRIUM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560316-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560317-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201204009959</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD AROUND NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOGENETIC ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560318-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560319-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201202008217</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110911</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIO</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LACTOSE INTOLERANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugbatchnumb>A931280</drugbatchnumb>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>18 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110904</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110828</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560320-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-ELI_LILLY_AND_COMPANY-IN201207008443</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 50/50</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560321-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-1092511</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugdosagetext>DOSE REPORTED AS 3MG/3ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560325-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR201207004104</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560326-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207006571</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560327-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201205008442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSFUNCTIONAL UTERINE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560328-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ELI_LILLY_AND_COMPANY-IT200702005331</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>2200 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE TARTRATE</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560329-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                                 /SCH/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COGNITIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560330-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201206007163</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugdosagetext>1 DF, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>405 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>1 DF, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG, UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560331-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugindication>WITHDRAWAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560332-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560333-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560334-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ELI_LILLY_AND_COMPANY-TR201205007514</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>24 IU QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>18 IU, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>20 IU QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560336-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ELI_LILLY_AND_COMPANY-SE201206009755</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560337-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-ELI_LILLY_AND_COMPANY-VE201207009323</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560338-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201203007898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA RELPREVV</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>300 MG, MONTHLY (1/M)</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560339-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201202007751</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA RELPREVV</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>210 MG, 2/M</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560340-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201206004912</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
        <drugdosagetext>35 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUICE PLUS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1 MG, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560341-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201207006235</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY MEDIASTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560342-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201206007517</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560343-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201207006318</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560344-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEAK EXPIRATORY FLOW RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560345-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-1093434</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560346-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1201USA02284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPLASTIC NAEVUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MORTON'S NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>400 U, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010601</drugenddate>
        <drugtreatmentduration>1403</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>2226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>976</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORPRAMIN</medicinalproduct>
        <drugdosagetext>25-100</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>4-8</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061208</drugenddate>
        <drugtreatmentduration>1731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560347-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-STX267833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560348-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1092436</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>DOSAGE IS UNCERTAIN, STRENGTH : 300</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560349-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ROCHE-1092893</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACPERAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>B1569</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 03/JAN/2011</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 10/20</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50/500</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50/500</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B6004</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 03/JAN/2011</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE: 5 AUC, LAST DOSE PRIOR TO SAE: 14/JUN2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>D8C648,D9A362</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 14/JUN/2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560350-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010719</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMENDIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLACET F</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID LOTION</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560351-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010995</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAUZELIN OD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560352-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-011112</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROHEPARUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNITRAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VEGETAMIN B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMEDIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIYA BM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560353-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-011118</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560354-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1092426</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPHANE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLSIDOMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMEX (GERMANY)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560355-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEFTAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560356-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DIVIDED DOSES OF 600 AND 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560357-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560358-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010958</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560359-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010986</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HICEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560360-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560361-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1094428</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORLISTAT</medicinalproduct>
        <drugauthorizationnumb>020766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560362-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560363-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560364-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560365-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16685BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560366-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1091896</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLCUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560367-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA02912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560368-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA007996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET XR</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560369-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1205USA02825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>ORAL,QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLACK COHOSH</medicinalproduct>
        <drugdosagetext>540 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBIDECARENONE</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALERIAN</medicinalproduct>
        <drugdosagetext>450 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAPE SEEDS</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ST JOHNS WORT</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINSENG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TURMERIC</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BORON (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLIUM HUSK</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3-ACETYL-7-OXO-DEHYDROEPIANDROSTERONE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CABBAGE PALM</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCARNITINE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
        <drugdosagetext>200 MICROGRAM, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAWTHORN</medicinalproduct>
        <drugdosagetext>565 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESVERATROL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOTU KOLA</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>200 MICROGRAM,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>99 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
        <drugdosagetext>140 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMELAINS</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGININE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANTHOPHYLL</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INOSITOL</medicinalproduct>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVENING PRIMROSE OIL</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1000 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOCTIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINGER</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAURINE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS ACIDOPHILUS (+) VITAMIN B COMPLEX</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOUR CHERRY</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560370-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17168BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>108864A,0C3211</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>108864A,0C3211</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>1200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIMB DISCOMFORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560371-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE39088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560372-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14011BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560373-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17132BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560374-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16280BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560375-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2011-BP-23216BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560376-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560379-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E7389-01597-CLI-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO GALLBLADDER</drugindication>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVACT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO LIVER</drugindication>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOREISAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110922</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO LYMPH NODES</drugindication>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAKKON-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO PERITONEUM</drugindication>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560380-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-749656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMALE GENITAL TRACT FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560381-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100822</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560382-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>396</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560383-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2011-117222</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RILMENIDINE</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560384-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110222</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200931462NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070519</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560385-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560386-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ABBOTT-12P-055-0960777-00</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF IMMUNOGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>GASTRO-RESISTANT TABLET, 2 TABS, 2 TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>ONCE DAILY, IF NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560387-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933285-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>5 TABLETS WEEKLY</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560388-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ABBOTT-12P-153-0962892-00</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560389-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095537</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>PEMPHIGOID</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINTROM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560390-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560391-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE38990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, 1 PUFF, IN THE MORNING, AS REQUIRED</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>3000436C0,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, TWO PUFFS, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>1 PUFF, IN THE AM AND 2 IN PM</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560392-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560393-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-798949</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>27</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISMODEGIB</medicinalproduct>
        <drugbatchnumb>800528</drugbatchnumb>
        <drugauthorizationnumb>203388</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE WAS 16 AUG 2011. TEMPORARILY INTERRUPTEDDOSAGE FORM UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BASAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110802</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISMODEGIB</medicinalproduct>
        <drugbatchnumb>800528</drugbatchnumb>
        <drugauthorizationnumb>203388</drugauthorizationnumb>
        <drugdosagetext>PERMANENTLY DISCONTINUED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
        <drugindication>ENURESIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN D DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>HYPOCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560394-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1096009</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMA SCALE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560395-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-058116</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugdosagetext>4.5 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugdosagetext>500 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBU</medicinalproduct>
        <drugdosagetext>600 MG, BY MOUTH, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
        <drugdosagetext>300 MG - 30 MG, 1 TAB BY MOUTH, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560396-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1210238US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CAROTID ARTERY STENOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE ATROPHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560397-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-783671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN (UNITED STATES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRACYCLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKNE-MYCIN (UNITED STATES)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO TRI-CYCLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560398-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-ROCHE-1095608</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>3+3</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560399-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>UY-ROCHE-1095098</companynumb>
    <primarysource>
      <reportercountry>URUGUAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560400-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560402-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1096064</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM CHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugauthorizationnumb>50585</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120115</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560403-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>STATUS ASTHMATICUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560404-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugindication>CELLULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560405-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20120700512</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugdosagetext>DURATION OF DRUG ADMINISTRATION=21 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMIPRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugdosagetext>DURATION OF DRUG ADMMINISTRATION=63 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugdosagetext>DURATION OF DRUG ADMINISTRATION=21 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugdosagetext>DURATION OF DRUG ADMMINISTRATION=63 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560406-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560407-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713194</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>NB868A</drugbatchnumb>
        <drugdosagetext>4 MG GUM, 20-22 GUMS A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>12837</drugbatchnumb>
        <drugdosagetext>4 MG LOZENGE, 20-22 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560408-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>LI819</drugbatchnumb>
        <drugdosagetext>2 MG GUM, 10 PIECES A DAY FOR 15 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560409-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110601</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>LG868</drugbatchnumb>
        <drugdosagetext>OVER A PERIOD OF 1 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560410-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120513494</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENZYME LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>CONFLICTINGLY REPORTED AS INFUSION # 107</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>107TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560411-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20091005602</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUCILLAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091014</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>SECOND DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FOURTH DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>THIRD DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTEC</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSMIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560412-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20111001806</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560413-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560414-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1095397</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL GRAFT LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID (UNK INGREDIENTS)</medicinalproduct>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560415-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-ROCHE-1095883</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560416-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1095865</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560417-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-1095760</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560418-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095780</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560419-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-011119</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESITAT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROHYPNOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOTAROMA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LULICON</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUDIOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIBITTOACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASACOLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560420-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1095025</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560421-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560422-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-577135</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS INTESTINAL HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>DRUG NAME: DOCETAXEL HYDRATE, DOSE FORM: 109 MG, LAST DOSE PRIOR TO SAE: 07 JAN 2009</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALURONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B3335</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 03 SEP 2008</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080922</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMEBUTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM REPORTED AS 143 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM REPORTED AS 955 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 24 SEP 2008</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 24 SEPT 2008</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B3335</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM REPORTED AS 950 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>N-METHYLSCOPOLAMINE METHYLSULFATE</medicinalproduct>
        <drugdosagetext>DRUG REPORTED AS METYL SCOPOLAMINE METYLSULFATE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560423-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-066390</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>21317</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KAWASAKI'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560424-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE39697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>2000162H00,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>80/4.5 MCG, ONE PUFF TWICE A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREATHING TREATMENT MEDICINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560425-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560426-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712687</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTED CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560427-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120612585</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560428-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN010967</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.2 MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5 MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>5MG/DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560429-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OXYGEN CONSUMPTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560430-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE39466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>3000446C00,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG,TWO PUFFS, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560431-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351214USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN AND DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE A+B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560432-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51658</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560433-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE33104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>500/5 MG EVERY 4 HOURS IF NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>0.4 MG EVERY FIVE MINUTED IF NEEDED</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560434-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA005698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugauthorizationnumb>020869</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560435-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560436-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DR. SCHOLL'S INGROWN TOENAIL PAIN RELIEVER</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560437-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, ONCE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560438-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA02845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERINEURIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAPE SEED OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560439-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP035847</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENANTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>FORMULATION: POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>72</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONA</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560440-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2010SP025088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080401</drugenddate>
        <drugtreatmentduration>547</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>2-3 TIMES PER MONTH (ROUTE NOT PROVIDED AND ^RECOMMENDED DOSAGE ON BOX^); ALSO REPORTED AS 4X/WK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560441-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE42760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560442-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52519</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560443-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560444-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE42669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugauthorizationnumb>020547</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560445-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-052388</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE:300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SIMPLE PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
        <drugtreatmentduration>136</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560446-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTEAL</medicinalproduct>
        <drugbatchnumb>420412</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560447-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-12P-008-0962679-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONGENITAL CARDIOVASCULAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560448-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961609-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145.28</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560449-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560450-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE42287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560451-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560452-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012182315</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>011719</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560457-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CN-01634CN</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560458-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16687BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVATED PARTIAL THROMBOPLASTIN TIME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560459-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN000603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugbatchnumb>A81294Q</drugbatchnumb>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560460-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200934556NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRI-SPRINTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE COLD AND SINUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHAMOMILE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560461-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE41806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugdosagetext>GENERIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>GENERIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560462-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2007UW13547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560463-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE34028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560464-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP017428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugbatchnumb>786002</drugbatchnumb>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110428</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560465-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011087</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>7 ANZ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugdosagetext>14 ANZ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>7 ANZ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>14 ANZ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>14 ANZ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>7 ANZ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENTAERYTHRITOL TETRANITRATE</medicinalproduct>
        <drugdosagetext>14 ANZ, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560466-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA012402</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>19.7 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110222</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORETIC</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MK-0683</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110222</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560467-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110502</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2010SP009187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLOFEMORAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHLAMYDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>1 DF, Q3W</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOROLAC TROMETHAMINE</medicinalproduct>
        <drugdosagetext>10 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081229</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE (+) MAGNESIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>1000 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>BID X 2 WEEKS, THEN QD X 8 WEEKS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560468-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560469-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0055751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>315</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560470-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-1094822</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560471-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560473-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1091917</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>25 MG/ 2 ML</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560476-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SHIRE-SPV1-2011-00938</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAGRELIDE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020333</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ESSENTIAL THROMBOCYTHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560477-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2012-03663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBCHORIONIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugauthorizationnumb>021977</drugauthorizationnumb>
        <drugdosagetext>70 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560478-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SHIRE-SPV1-2011-01212</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FIRAZYR</medicinalproduct>
        <drugauthorizationnumb>022150</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEREDITARY ANGIOEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110902</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560479-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SHIRE-ALL1-2011-02141</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA UNSTABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENIERE'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>750 MG (IMMEDIATELY AFTER MEALS), 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090531</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090702</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>5 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110531</drugenddate>
        <drugtreatmentduration>92</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>1.5 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>1500 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>10 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091031</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>25 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100917</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESULAN</medicinalproduct>
        <drugdosagetext>1 DF, UNKNOWN</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORINAEL</medicinalproduct>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>750 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>1500 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100429</drugenddate>
        <drugtreatmentduration>195</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>15 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100430</drugenddate>
        <drugtreatmentduration>74</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHUBARB</medicinalproduct>
        <drugdosagetext>3 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>750 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090626</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>30 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>20 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110131</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>10 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110228</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>1500 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugdosagetext>2 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>250 MG, 1X/DAY:QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090612</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>2250 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>20 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090915</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>10 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK (1A/3WEEKS), UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMORRHAGE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC B</medicinalproduct>
        <drugdosagetext>3 G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSRENOL</medicinalproduct>
        <drugauthorizationnumb>021468</drugauthorizationnumb>
        <drugdosagetext>750 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091016</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAROL</medicinalproduct>
        <drugdosagetext>15 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090731</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560480-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1083540</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>PT1036H02A</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE ON 19/APR/2012</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE ON 27/MAR/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560481-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1087158</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>36</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>AUC4</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560482-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1091873</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.836</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>B60331,B60211</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560483-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-BRACCO-000018</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugauthorizationnumb>18735</drugauthorizationnumb>
        <drugdosagetext>IN THE SUBARCHNOID REGION</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IOPAMIDOL</medicinalproduct>
        <drugauthorizationnumb>018735</drugauthorizationnumb>
        <drugdosagetext>IN THE SUBARCHNOID REGION</drugdosagetext>
        <drugindication>SPINAL MYELOGRAM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560484-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE39196</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>644</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SERUM FERRITIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560485-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2009SE24008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>842</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE URIC ACID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C ESTER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOMALIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091026</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugdosagetext>100 MG 18 PILLS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCREASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560486-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560490-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2012041178</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>UNK UNK, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111215</drugenddate>
        <drugtreatmentduration>904</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FALKEN</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYALEIN</medicinalproduct>
        <drugdosagetext>ADEQUATE/AS NECESSARY</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
        <drugdosagetext>ADEQUATE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDRON</medicinalproduct>
        <drugdosagetext>AS NECESSARY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>ADEQUATE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560491-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101019</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200935089NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIRSUTISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070821</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070925</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVERA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>I.V. SOLUTIONS</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560492-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959957-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022224</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DYRENIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560493-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961528-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.87</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560494-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00FZ</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560495-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560496-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076596</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EVX</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560497-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200934737NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111.57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY DOSE), QD,</drugdosagetext>
        <drugindication>MOOD SWINGS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090314</drugenddate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560498-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP011808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSVERSE SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>0.12-0.015 MG/24 HRS</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560499-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2009UW06904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560500-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>E00976,,,</drugbatchnumb>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560501-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560503-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE35528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560504-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560505-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010091171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>9 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY, X 28 DAYS Q 42 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY, 4/2 SCHEDULE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560506-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2012185719</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK UG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560507-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070604</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185597</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugauthorizationnumb>019885</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE</medicinalproduct>
        <drugdosagetext>100-300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560508-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070615</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185114</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>QUINAPRIL/HYDROCHLOROTHIAZIDE 20/12.5 MG 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>OLMESARTAN/HYDROCHLOROTHIAZIDE 20/12.5 MG 1X/DAY</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>30 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>60 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560509-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012180819</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGRANULOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>25 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>3 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
        <drugtreatmentduration>796</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560510-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012184491</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560511-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560512-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012172787</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560513-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560514-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2012046834</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>30 MUG, QMO</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110706</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>40 MUG, QMO</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
        <drugtreatmentduration>150</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560515-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012002710</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
        <drugtreatmentduration>53</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
        <drugtreatmentduration>203</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560516-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012183476</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560517-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560518-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.517</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>7.5 MG, DAILY</drugdosagetext>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XIFAXAN</medicinalproduct>
        <drugdosagetext>550 MG, 2X/DAY</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560519-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012179256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560520-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012176291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560521-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012162455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK, 5/500 AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MITRAL VALVE PROLAPSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK, 3/XDAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG DAILY, FIRST 42 DAY CYCLE</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MITRAL VALVE PROLAPSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>UNK, 25 UGM</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560522-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012183878</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560523-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012184260</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560524-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012186989</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TALIGLUCERASE ALFA</medicinalproduct>
        <drugauthorizationnumb>22458</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560525-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP011830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560526-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-011128</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560527-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2011-001762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560528-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-003188</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PETROLATUM SALICYLATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE OINTMENT</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560529-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOULDER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPORTS INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC NECK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SELEGILINE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOFEN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560530-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351439USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugbatchnumb>PAB25A</drugbatchnumb>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugdosagetext>2 INHALATIONS EVERY 3-4 HOURS AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560531-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200932821NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>100 MG (DAILY DOSE), QD, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>213</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG (DAILY DOSE), QD, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560532-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200935705NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METAPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS ATROPHIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANALGESICS AND ANTIPYRETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAYA ENZYME</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>5/500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560533-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200936232NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTREMITY CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC SYSTEMIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>DOSE: 800-1200MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>19596</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>15 ML, UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061013</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>50 ML OMNISCAN+CO2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FISTULOGRAM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENOFER</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHOSLO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM IN UNSPECIFIED DRUG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNISCAN</medicinalproduct>
        <drugdosagetext>20 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060805</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROHANCE</medicinalproduct>
        <drugindication>COMPUTERISED TOMOGRAM HEAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTIMARK</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>20 ML, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061017</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560534-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>40 MG, AT 3 AM IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>GENERIC</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>40 MG, AT 3 AM IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560535-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE37819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560536-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE13573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560537-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ALLERGAN-1210310US</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugdosagetext>50 UNITS, SINGLE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugbatchnumb>C2992</drugbatchnumb>
        <drugdosagetext>32 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560541-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560542-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560543-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA012776</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAVOPROST AND TIMOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugauthorizationnumb>20408</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560544-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CERVICAL VERTEBRAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560552-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-IT-00173IT</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DROP ATTACKS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>180 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugdosagetext>550 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560553-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00886UK</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANY OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560554-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17058BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560555-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-TEVA-252520ISR</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>071617</drugauthorizationnumb>
        <drugdosagetext>15 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560556-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING SPINAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560557-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-200914174BYL</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560558-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100616</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200936814NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021213</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM 99</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>50-12.5</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560559-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100923</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200938824NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>PHARMACY RECORDS: 08-JUL-2009 TO 27-OCT-2009</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091027</drugenddate>
        <drugtreatmentduration>417</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560560-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POTENTIATING DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKA SELTZER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560561-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1206378US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTOX COSMETIC</medicinalproduct>
        <drugbatchnumb>C2986</drugbatchnumb>
        <drugdosagetext>25 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SKIN WRINKLING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560562-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KE-GILEAD-2012-0058958</companynumb>
    <primarysource>
      <reportercountry>KENYA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560563-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560564-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560565-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE40312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>STARTED IN 2005-2006</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560569-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-2011005774</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugdosagetext>QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>T-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110429</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560570-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351372USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>074739</drugauthorizationnumb>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560571-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012179440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SIZE ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>1879821</drugbatchnumb>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560572-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560573-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560574-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560575-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PURDUE-USA-2012-0090763</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VICTIM OF HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>19516</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560579-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-340582ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IATROGENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XENAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
        <drugauthorizationnumb>021641</drugauthorizationnumb>
        <drugindication>PARKINSONISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560580-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560581-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560582-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560583-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560584-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560585-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560586-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560587-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560588-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560589-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560591-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560592-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560593-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560594-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560595-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560596-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560597-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560598-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560599-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-347634ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076119</drugauthorizationnumb>
        <drugdosagetext>45 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>650 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
        <drugtreatmentduration>1975</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugtreatmentduration>1975</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>1975</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560600-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200938967NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
        <drugtreatmentduration>340</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560601-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1002493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>70 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560602-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ABBOTT-12P-035-0961684-00</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090619</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560603-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP036333</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>FORMULATION: POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>FORMULATION: POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>FORMULATION: POR  AMLODIPINE BESILATE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>FORMULATION: POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROTYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>FORMULATION: POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>FORMULATION: POR, TRADE NAME: UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560604-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090712</drugenddate>
        <drugtreatmentduration>5305</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560605-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1205FRA00026</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PORTAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDIATOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>21995</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560606-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DWARFISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560607-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>150 MGS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560611-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351337USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMEDIATE POST-INJECTION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560612-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560613-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS MUCOSAL LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560614-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560615-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350274ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065154</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560617-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560618-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE45687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560619-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560621-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2012-0058341</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAEVUS FLAMMEUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>1 DF (200/245MG), QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION CDC CATEGORY B2</drugindication>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION CDC CATEGORY B2</drugindication>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION CDC CATEGORY B2</drugindication>
        <drugtreatmentduration>281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560622-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-004048</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILMAG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOCHUEKKITO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560623-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-003623</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NESPO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NESPO</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDEKOPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560624-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100921</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200939394NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090221</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560625-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560626-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43501</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560627-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BG-ASTRAZENECA-2012SE53234</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560628-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560629-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MPIJNJ-2012-05217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.0 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560630-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-CERZ-1002561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACQUIRED IMMUNODEFICIENCY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREPONEMA TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>60 U/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560631-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560632-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MPIJNJ-2011-03521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>21602</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560636-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugauthorizationnumb>020547</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
        <drugauthorizationnumb>020547</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560637-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTRAZENECA-2012SE52823</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugauthorizationnumb>019726</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560638-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR065402</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGOENCEPHALITIS HERPETIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSEOLOVIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugauthorizationnumb>070268</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560639-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012146613</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560640-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRING</medicinalproduct>
        <drugauthorizationnumb>020472</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560641-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012155612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, CYCLIC</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560642-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SEXUAL AROUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALE ORGASMIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560643-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012129961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560644-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560645-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560646-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560647-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012058817</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560648-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012141896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugbatchnumb>R040676</drugbatchnumb>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560649-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC LYMPHOCYTIC LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN-MINERAL COMPOUND TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560650-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186503</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>429</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560651-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560652-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012153493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RADIUS FRACTURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560653-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012186521</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560654-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP057493</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugauthorizationnumb>020539</drugauthorizationnumb>
        <drugdosagetext>125 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ONYCHOMYCOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560655-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR029557</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL POVERTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560656-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IL061582</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, QD (2.5 MGX 2)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560657-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560658-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011US52921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS MUCOSAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURODEGENERATIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0006A</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>UNK UKN, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXATIVES</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560659-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012HU010501</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REBOUND EFFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>463</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADJUVANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSOL A</medicinalproduct>
        <drugdosagetext>500 ML, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUAMATEL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADJUVANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.25 MG, BID</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALSOL A</medicinalproduct>
        <drugdosagetext>500 ML, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560660-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-PFIZER INC-2011287310</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560661-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012IE004168</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560662-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065469</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPHYXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugdosagetext>300 UG, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560666-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT063326</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugauthorizationnumb>072151</drugauthorizationnumb>
        <drugdosagetext>6 MG, DAILY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>0.8 MG, DAILY</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETA-2</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560667-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560668-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>25 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560669-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012153328</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>19901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, ONCE DAILY IN THE MORNING</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560671-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE HALF TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560672-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012115055</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560673-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560674-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, ALTERNATE DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560675-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50711</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050711</drugauthorizationnumb>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560676-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugindication>DIABETIC FOOT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021130</drugauthorizationnumb>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560677-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350286ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065154</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560678-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTING MONTH PACK AND 1 MG REFILLS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560679-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560680-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012168206</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORISEL</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560681-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2009205355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.261</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560682-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-TESTOSTERONE</medicinalproduct>
        <drugbatchnumb>11106301</drugbatchnumb>
        <drugauthorizationnumb>085635</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560683-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012156298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560684-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012111145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG AND 1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560685-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560686-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012111156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNARIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5MG/1MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560687-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0019</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560688-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR056263</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMINYL ER (GALANTAMINE HYDROBROMIDE)</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLDOPA</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 DF (AT MONDAY TO FRIDAY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFIBRATE</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560689-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA88840</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.689</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560690-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR048430</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugdosagetext>150 UG,1INHALATION PER DAY</drugdosagetext>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560691-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012LU062037</companynumb>
    <primarysource>
      <reportercountry>LUXEMBOURG</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560693-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IT034224</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
        <drugtreatmentduration>134</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560694-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE THOUGHTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD TITUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERY LOW DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABILE HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG TWO TAB AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG FOUR TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>4 DF, QD (2 TABLET IN MORNING AND 2 AT NOON)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>90 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>2 DF, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>5 UG, BID</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK UKN, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560695-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR058598</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110426</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XATRAL EXTENDED RELEASE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>PROSTATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560696-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB065049</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076189</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560697-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP043793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERWEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARTHOLIN'S CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSFUNCTIONAL UTERINE BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METABOLIFE 356</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560698-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugauthorizationnumb>021231</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560699-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012TW066159</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELBIVUDINE</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560701-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD AND NECK CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560702-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560703-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISSECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>F1128</drugbatchnumb>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560705-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0012B</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0012B</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560706-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066323</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560707-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF (320/25 MG), UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>1 DF (320/25 MG), UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560708-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR04324</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>1440 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RASILEZ (ALISKIREN)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>20 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>350 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>3 PILL PER WEEK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560709-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004267</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL INFECTION FEMALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560710-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004252</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALISKIREN</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORACTEN</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560711-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU064506</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>450 MG, NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560712-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR055977</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>10 DRP, Q6H</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0025</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560713-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE045751</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMEAR CERVIX ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>125 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560714-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009AU37546</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPULSE-CONTROL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>25 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN D DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>0.5 MG, BID</drugdosagetext>
        <drugindication>MOOD ALTERED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMIPRAMINE HCL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560715-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU062359</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560716-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR038895</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF DAILY</drugdosagetext>
        <drugindication>BLOOD DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>21283</drugauthorizationnumb>
        <drugdosagetext>320 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugdosagetext>150 UG, UNK</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>2 DF DAILY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>2 DF DAILY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560718-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB002988</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560719-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugbatchnumb>59583</drugbatchnumb>
        <drugauthorizationnumb>020538</drugauthorizationnumb>
        <drugdosagetext>0.05 MG, Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>500 MG, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560720-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012FR000610</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETROZOLE</medicinalproduct>
        <drugauthorizationnumb>020726</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120103</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560721-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR042070</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>2 DF (1 DF BEFORE BREAKFAST AND , A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>20 CC ON THE MORNING AND 10 CC AT NIGHT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOCOMB SI</medicinalproduct>
        <drugdosagetext>2 DF (80 MG VALSARTAN AND 20 MG SIMVASTATIN), A DAY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASTAREL</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>20818</drugauthorizationnumb>
        <drugdosagetext>1 DF (320 MG VALSAR AND 12.5 MG HYDRO), DAILY AFTER BREAKFAST</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560722-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>4 G, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560723-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugauthorizationnumb>020538</drugauthorizationnumb>
        <drugdosagetext>0.1 UKN, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560724-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012HU042758</companynumb>
    <primarysource>
      <reportercountry>HUNGARY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560725-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYFORTIC</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>360 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560726-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010IE18890</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110105</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>NO TREATMENT RECEIVED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>22334</drugauthorizationnumb>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101211</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATECOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>80 MG/M2 DAY 1,8,5 OF 28 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>380 MG, UNK</drugdosagetext>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>NO TREATMENT RECEIVED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101220</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>VULVOVAGINAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101220</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>190 MG, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101207</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560728-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN062738</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560729-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012CA008390</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>021560</drugauthorizationnumb>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>345</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560730-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003640</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>325 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560731-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2011GB02338</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>350 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560732-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>5 ML, BID</drugdosagetext>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560733-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560734-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004258</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560736-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US010941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560737-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US011739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>5000 U, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0013A</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560738-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012US011198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.501</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>667</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED</medicinalproduct>
        <drugdosagetext>NO TREATMENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>667</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>375</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>18569</drugauthorizationnumb>
        <drugdosagetext>80 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>667</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>784</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560739-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL ARTERY DISSECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugauthorizationnumb>091659</drugauthorizationnumb>
        <drugindication>THORACIC OUTLET SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>THORACIC OUTLET SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugindication>THORACIC OUTLET SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560740-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU065064</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugauthorizationnumb>75049</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560741-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugauthorizationnumb>008662</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugindication>LATENT TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560742-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065905</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CRANIOFACIAL DYSOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW BIRTH WEIGHT BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYMUS HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugauthorizationnumb>077424</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560743-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00255UK</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRICANYL</medicinalproduct>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>200 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560744-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16670BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugdosagetext>20 MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVOXAC</medicinalproduct>
        <drugdosagetext>90 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SJOGREN'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPYLENE GLYCOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560745-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16692BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560746-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-PERC20120096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>040330</drugauthorizationnumb>
        <drugdosagetext>5MG/325MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560749-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU065050</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560750-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-FF-00746FF</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560751-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-JNJFOC-20120713736</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560752-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713867</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560753-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KZ-JNJFOC-20120713103</companynumb>
    <primarysource>
      <reportercountry>KAZAKHSTAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560754-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713677</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560755-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120713738</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>2 INFUSIONS RECEIVED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560756-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560757-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560758-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560759-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715374</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560760-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120515314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560761-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-074847</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugauthorizationnumb>020198</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560762-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BAYER-2011-077032</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110903</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTONE</medicinalproduct>
        <drugdosagetext>20 MG IN AM 10 MG IN PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, OM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEGALON</medicinalproduct>
        <drugdosagetext>1 A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111004</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>0.05 MG, OM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1 IN THE EVENING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560763-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560764-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMPAT</medicinalproduct>
        <drugauthorizationnumb>022253</drugauthorizationnumb>
        <drugdosagetext>AM</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560765-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0051809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560766-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560767-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560768-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560769-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560770-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.388</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE COATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD TESTOSTERONE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, 3X/DAY (TAKE ONE 12.5MG CAPSULE THREE TIMES A DAY FOR A TOTAL OF 37.5MG / DAY)</drugdosagetext>
        <drugindication>HEPATIC CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>MUSCULOSKELETAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATIC PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560772-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012176004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560773-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012142542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN JR.</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560774-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012177929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>QUADRIPLEGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1 G, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>60 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENTEROCOCCAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560775-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012163953</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>200 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120110</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120119</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560776-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012174303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALDOSTERONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560777-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012143034</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>636</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FONDAPARINUX SODIUM</medicinalproduct>
        <drugdosagetext>7.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560778-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012105945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560779-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20091011</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185551</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560780-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012165697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.36</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560781-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugauthorizationnumb>021231</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560782-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ASTRAZENECA-2012SE53615</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560783-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012150150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, TAKE ONE TABLET DAILY 1 HOUR BEFORE NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560784-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012183930</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560785-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012118919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.481</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELLS URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG DAILY X28 DAYS Q 42 DAYS</drugdosagetext>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMETROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE EXTENDED RELEASE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560786-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012166415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugbatchnumb>C121647</drugbatchnumb>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>600 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560787-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51508</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560788-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012158602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN-125</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560789-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-FLUD-1001525</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>200 MCG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>300 MCG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2 G/M2, ON DAYS -6 TO -2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>10 MG/M2 ON DAYS -6 TO -4</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>30 MG/M2, ON DAYS -6 TO -2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CORD BLOOD TRANSPLANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>150 MCG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560790-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>ANTIBIOTIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560791-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MSD-1207GBR001552</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19941205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>450 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>450 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560792-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SAVIENT-2012S1000075</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>155.22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KRYSTEXXA</medicinalproduct>
        <drugbatchnumb>1037A</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KRYSTEXXA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KRYSTEXXA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560793-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-344596USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560794-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugauthorizationnumb>021231</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560795-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE47558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH D VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOPHEDRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560796-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugauthorizationnumb>021231</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560798-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0987940A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugauthorizationnumb>020165</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560802-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAYER-2012-077474</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugbatchnumb>13053G</drugbatchnumb>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>7.5 ML, ONCE</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560803-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20120712040</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugdosagetext>FOR 4 WEEKS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLDORM</medicinalproduct>
        <drugdosagetext>0.5 OF 10 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560804-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120714067</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560805-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120703496</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>21169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560806-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-009507513-2009SP029541</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>021249</drugauthorizationnumb>
        <drugdosagetext>0.5 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560808-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-009507513-1207DNK000575</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>DOSIS: 100 MG 1 GANG DAGLIGT, STYRKE: 100</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560809-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1102USA00900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031203</drugenddate>
        <drugtreatmentduration>1067</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>ORAL 10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DENSITY DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, QM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100304</drugenddate>
        <drugtreatmentduration>1186</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560810-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-NOVOPROD-356311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560811-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE46430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40MG, ON THE DAYS NOT TAKING THE 20MG DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40MG, ON THE DAYS NOT TAKING THE 20MG DOSE.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560812-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE37436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHOTILLOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OBSESSIVE-COMPULSIVE DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560813-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE25150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>300-500 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 2-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 2-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 3-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 3-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>THREE TO FIVE TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>300-500 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>5000 U</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>UP TO 6 TABLETS DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>UP TO 6 TABLETS DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>UP TO 6 TABLETS DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE ER</medicinalproduct>
        <drugdosagetext>500 MG DIALY WITH TID FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>300-500 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 2-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 3-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>THREE TO FIVE TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>10-20 DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MANIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>300-500 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 2-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>1 TABLET DAILY, 3-5 TABLETS AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>UP TO 6 TABLETS DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>THREE TO FIVE TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>THREE TO FIVE TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560814-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958378-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560819-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-FLUD-1001522</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENGRAFTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020038</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOTAL BODY IRRADIATION</medicinalproduct>
        <drugdosagetext>4 GY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560820-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE51364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>80/4.5 MCG - TAKEN DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG - PRESCRIBED DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560821-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE W/ CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS VIRAL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560822-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-PFIZER INC-2012182791</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>10151</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560823-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011057676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACOUSTIC NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR LENS IMPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024943</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSTAVAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PNEUMOVAX 23</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>5000 MUG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 IU, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1.2 G, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560824-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-UCBSA-062770</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560825-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSOCIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugdosagetext>1000 MG AT BEDTIME</drugdosagetext>
        <drugindication>INTERMITTENT EXPLOSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHETAMINE AND DEXTROAMPHETAMINE SALTS</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugauthorizationnumb>072499</drugauthorizationnumb>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugdosagetext>500 MG IN THE MORNING, 750 MG AT BEDTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560827-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-784572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGONADISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19840201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19840601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560828-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560829-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1006969</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>4 MG/KG/DOSE</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560830-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1095711</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560831-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110430</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-1094927</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS INFECTIOUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560836-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2012-075245</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560837-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-713124</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERRAPEPTASE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBROXOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFCAPENE PIVOXIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>RESCUE THERAPY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN SODIUM</medicinalproduct>
        <drugdosagetext>AS NEEDED.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OCRELIZUMAB</medicinalproduct>
        <drugauthorizationnumb>011421</drugauthorizationnumb>
        <drugdosagetext>PATIENT WITH DRAWN FROM STUDY ON 19 OCT 2009.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE AND PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560838-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-UCBSA-062152</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560839-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE22546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560840-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE INJURIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560841-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GENZYME-CLOF-1002225</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560847-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-UCBSA-060806</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 ,20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>DOSE : 500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560848-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE33828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>GENERIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560849-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012181442</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>3 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INTRAOCULAR PRESSURE TEST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560850-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V120518</drugbatchnumb>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURNING SENSATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 UG, DAILY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560851-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012161059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>V111920</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560852-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560853-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560854-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE08609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560855-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00884UK</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE</medicinalproduct>
        <drugdosagetext>16 MG</drugdosagetext>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560856-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-DE-00710DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560857-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AU-00999AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugindication>ATRIAL FLUTTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>4000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560858-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17290BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560859-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17037BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>162 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560860-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961727-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA LEGIONELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560861-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-DE-01702DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR HYPOTHYREOSIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>INTERNATIONAL NORMALISED RATIO</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560862-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17036BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560868-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00788UK</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>INJ</drugdosagetext>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>4 DOSAGE FORMS (2 DOAGE FORMS, 2 IN 1D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560869-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AP-00526RI</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560870-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ASTRAZENECA-2012SE43192</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560871-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560872-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE37243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPY REGIMEN CHANGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>GENERIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560873-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MYLANLABS-2012S1014696</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>0</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LONG QT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE REGULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEEDING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugauthorizationnumb>077166</drugauthorizationnumb>
        <drugdosagetext>150 [MG/D ]/ REDUCED UNTIL GW 26, THEN STOP OF TREATMENT</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 [MG/D ]</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560874-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1107USA03268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISCITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560875-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-UCBSA-062751</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIANICOTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560876-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560877-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FLUTTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560878-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GENZYME-CLOF-1002228</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>330 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560885-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16803272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT SUBQ INJECTION 125MG/ML</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560886-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16614265</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT DOSE 80MG/M2, ON 3MAY12 INF 5,</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>25MG/M2 DAY 1 AND DAY 8 OF EACH 3WK CYCLE. RECENT DOSE 25MG/M2, INF 10, 10MAY12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>CETUXIMAB 5MG/ML RECENT DOSE 250MG/M2,INF 14, 10MAY12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560887-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012148312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>50 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE/ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugauthorizationnumb>8697</drugauthorizationnumb>
        <drugdosagetext>20 MG IN MORNING, 5MG AT 2PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugauthorizationnumb>008697</drugauthorizationnumb>
        <drugdosagetext>20 MG IN MORNING AND 5MG AT 2PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS ACIDOPHILUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUCAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560888-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012157827</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>500 MG/M2, DAY1 (FISRT CYCLE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>85 MG/M2 EVERY DAY</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>180 MG/M2, DAY2 (FIRST CYCLE)</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugdosagetext>85 MG/M2, IN SPLIT DAILY DOSES FOR 3 DAYS, ALTERNATING WITH FLUOROURACIL, STARTING ON DAY2</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040023</drugauthorizationnumb>
        <drugdosagetext>2800 MG/M2 EVERY DAY</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>500 MG/M2 EVERY DAY (FOURTH CYCLE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>180 MG/M2 (FOURTH CYCLE)</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040023</drugauthorizationnumb>
        <drugdosagetext>2800 MG/M2, IN SPLIT DAILY DOSES FOR 3 DAYS, ALTERNATING WITH OXALIPLATIN INFUSION, STARTING ON DAY2</drugdosagetext>
        <drugadministrationroute>013</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560889-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012147721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.458</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAFAMIDIS MEGLUMINE</medicinalproduct>
        <drugauthorizationnumb>71880</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>12.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, 3 TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
        <drugtreatmentduration>361</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>6 MG, 4 TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560890-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012157559</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5.0 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>75 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>UNK MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>019901</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560891-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560892-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012154967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR FLARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>500 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>300 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>604</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560893-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012160199</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG (FREQUENCY NOT SPECIFIED)</drugdosagetext>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560894-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDROPNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120415</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>16793</drugauthorizationnumb>
        <drugdosagetext>16540 MG, TOTAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>140 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050467</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120408</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugdosagetext>700 MG, TOTAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120408</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>011719</drugauthorizationnumb>
        <drugdosagetext>1382 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESNA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560895-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012179588</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>16793</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>016793</drugauthorizationnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACICLOVIR</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560896-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA PAROXYSMAL NOCTURNAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560897-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560898-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BRISTOL-MYERS SQUIBB COMPANY-16654121</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugbatchnumb>1-K68639</drugbatchnumb>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugdosagetext>APPROX. 15 DAYS AGO 100MG:3DEC11-08DEC11 140MG:9DEC11-19JAN12 100MG:23JAN-8FEB12 70MG:9-18FEB12</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIOLYTIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560899-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-TEVA-350129GER</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>073178</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIANSERIN</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>.4 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>UP TO 5 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugauthorizationnumb>073178</drugauthorizationnumb>
        <drugdosagetext>1200 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>4 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STATUS EPILEPTICUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>150 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560900-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-16772535</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOVOLAEMIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>1DF=1 DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>1DF=2 DOSES</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CEREBRAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>1DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOPRAL</medicinalproduct>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560902-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BRISTOL-MYERS SQUIBB COMPANY-16680266</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DASATINIB</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560903-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP036764</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100MG/DAY, AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.2MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE</medicinalproduct>
        <drugdosagetext>TWICE/DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX (MAGNESIUM OXIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOMEX</medicinalproduct>
        <drugdosagetext>TWICE/DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG/DAY, AS NEEDED.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX (MAGNESIUM OXIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560904-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1110USA02741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE V HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE-A-DAY ESSENTIAL VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>18250</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080203</drugenddate>
        <drugtreatmentduration>2814</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110328</drugenddate>
        <drugtreatmentduration>1119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560905-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1201USA02541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
        <drugtreatmentduration>2921</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
        <drugtreatmentduration>2257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560906-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16812729</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>INF</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560907-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16692444</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YERVOY</medicinalproduct>
        <drugdosagetext>LAST INF ON 24MAY2012 INF:2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560908-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BRISTOL-MYERS SQUIBB COMPANY-16606352</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT SOLUBILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUESTRAN</medicinalproduct>
        <drugbatchnumb>419</drugbatchnumb>
        <drugauthorizationnumb>016640</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560909-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16807067</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560910-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-16799199</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1DF: HALF TAB IN EVERY MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>139202</drugbatchnumb>
        <drugauthorizationnumb>020758</drugauthorizationnumb>
        <drugdosagetext>1DF: HALF TAB APROZIDE 300MG+12.5MG COATED TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560911-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-004053</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560912-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugauthorizationnumb>021116</drugauthorizationnumb>
        <drugdosagetext>75 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugauthorizationnumb>021116</drugauthorizationnumb>
        <drugdosagetext>75 MCG MONDAY-SATURDAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560913-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-006010</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560914-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-006323</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHYTHMY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560915-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560916-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560917-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560918-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-006307</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIKKUNSHI-TO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120415</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEDEKOPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560919-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007082</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560922-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-058661</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, BATCH NO: UNKNOWN</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE:7.5</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE:15</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560924-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1094281</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560925-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207006558</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560926-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201207001099</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugdosagetext>10 U, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A897247J</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHO-NITRO PUMPSPRAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETADERM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D-TABS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560927-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008389</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INVESTIGATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>100 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>C003598L</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560928-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201203006904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFLEX                            /00943602/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>6000 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A883534G</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560929-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207006970</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560930-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560931-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201111007702</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560932-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201108005313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877625C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560933-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201010006566</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110129</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110405</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROTROPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXAL PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560934-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ELI_LILLY_AND_COMPANY-IL201208000285</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMITEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560935-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201108004574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840122F</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A865644C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRED FORT</medicinalproduct>
        <drugindication>CORNEAL TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560936-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206007061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877522K</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560937-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201201006665</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A951347E</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A951347E</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560938-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX201207008428</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560939-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207006932</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560940-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201207007534</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLEPHAROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560941-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201205010155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PATELLA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840122F</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 U, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560942-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008320</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560943-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008309</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE GRAFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560944-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201203006695</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A948707C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560946-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207007504</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560947-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007936</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560948-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207000042</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>0.625 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>7 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>7.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugdosagetext>37.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>7 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMBOCOR</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>0.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SCOLIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIGLITOL</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560949-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201204006587</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560950-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207008289</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560951-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201105001217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A788788K</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560952-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008324</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560953-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR201207008020</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560954-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201109002074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q-10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A872709C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A842600F</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840123C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877625C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560955-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW MAG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877625C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560956-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008279</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560957-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207008225</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560958-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207006974</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560959-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201101002984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A883536C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG, EACH EVENING</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MG, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA LAXATIVE</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A666304C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560960-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201102002165</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110217</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560961-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201207008582</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
        <drugtreatmentduration>353</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOLTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560963-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207007901</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560964-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-ELI_LILLY_AND_COMPANY-KR201207008035</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560965-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201110008041</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560966-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560967-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201205005843</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560968-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008431</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560969-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1003096</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>155 MG, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110808</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560974-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BAYER-2012-076994</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>250 ?G, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>567</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560975-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDOL PM CAPLETS</medicinalproduct>
        <drugbatchnumb>215730K</drugbatchnumb>
        <drugdosagetext>2 DF, ONCE, BOTTLE COUNT 20S</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560977-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008433</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560978-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201107002802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.399</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A888230C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A819978L</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560979-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201206004444</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SENSITISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560980-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201205003390</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM SANDOZ</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACFOL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A946172H</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLOTIL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINOGAN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>3 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLORAZEPATE DIPOTASSIUM</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMPORTAL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIDROFEROL</medicinalproduct>
        <drugdosagetext>2 DF, OTHER</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560981-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-ELI_LILLY_AND_COMPANY-GR201207007655</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560982-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-ELI_LILLY_AND_COMPANY-TW201207008451</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNOSIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560983-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560985-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560986-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7116875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU001773</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560987-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961548-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ECZEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560988-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-10P-087-0682403-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYPHILIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>4 DOSAGE FORMS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021226</drugauthorizationnumb>
        <drugdosagetext>6 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061126</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 DOSAGE FORM DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560989-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350730USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560990-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19860407</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-86040306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRONGYLOIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0152</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAGNOSTIC RADIOPHARMACEUTICAL (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560991-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugbatchnumb>1JS322</drugbatchnumb>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugdosagetext>1 STANDARD DOSE OF 60</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560992-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE59108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH IMPACTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560993-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8560999-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16673436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561000-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16673741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>ON THERAPY FOR MORE THAN 5 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561001-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16674186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561002-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16677551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>DOSE:300MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561003-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16677643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>ON THERAPY FOR MORE THAN 5 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561004-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16677650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>ON THERAPY FOR MORE THAN 5 YEARS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561005-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16684185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE ON 20MAR12</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561006-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16686735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>2B022A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561007-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16696668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561008-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15541469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561009-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15579493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>OH5002A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>STARTED WITH 150MG INSTEAD OF 300MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561010-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15785181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>TABLETS</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561011-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15844517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>REYATAZ 400 MG, 2 OF THE 200 MG ONCE DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561012-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15857725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM PR PROLONGATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561013-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15859762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPODYSTROPHY ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS PARALYTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOHYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIDRADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGOTONSILLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugdosagetext>1DF:3.5CC</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>1DF:3/4 TAB 150 UNITS NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugdosagetext>1DF:50 UNITS NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1 DF : 300/200 UNITS NOS</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRACEPT</medicinalproduct>
        <drugdosagetext>1DF:6 PILLS,1500 UNITS NOS STRENGTH:350MG 1250 BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYAMBUTOL</medicinalproduct>
        <drugdosagetext>1DF:200 UNITS NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>1DF:80 NOS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugdosagetext>1DF:1 CAPSULE ALSO 20MG BID</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugdosagetext>ALSO 250 UNITS NOS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561014-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15879026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561015-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15888605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561016-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15897234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561017-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15911811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561018-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15914096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561019-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15920929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561020-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15920978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1 DF: 1 UNIT NOS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561021-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15932643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561022-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15937774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561023-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15937931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561024-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15947757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561025-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15950256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561026-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15952302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561027-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15961881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561028-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15962590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561029-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15985799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561030-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15985930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD UREA ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561031-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15986052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>REYATAZ CAPSULE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561032-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15986425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561033-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15989791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561034-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15992118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561035-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15993850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>1DF:2 UNITS NOS 200MG CAPS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561036-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15994585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561038-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16021503</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561039-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16028334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561040-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16038473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561041-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16042913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NORMAL NEWBORN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIROLOGIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED TO 400MG AT 7TH MONTH</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561042-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16054959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561043-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16067787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>21567</drugauthorizationnumb>
        <drugdosagetext>SATRTED 2 WEEKS AGO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>SATRTED 2 WEEKS AGO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>SATRTED 2 WEEKS AGO</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561044-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16089120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561045-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16140071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPSONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1DF=200/300(UNITS NOT SPECIFIED).</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561046-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16172454</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561047-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16177347</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>1 DF=300/100 UNITS NOS</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561048-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16180515</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561049-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16193377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561050-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16206138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1G5020A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561051-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16222259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDEX</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561052-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16231656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1G5006A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STAVUDINE</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561053-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16258063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561054-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16262131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561055-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16273252</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1E5127A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561056-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16280182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>LIQUID FORM.</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561057-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16293052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIORICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561058-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16297707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561059-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16306201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561060-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16310989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1E5127A,2A006A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>REYATAZ FOR A ABOUT A WEEK NOW.LOT#2A5006A,EXP DT:20JAN2014</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561061-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16319790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561062-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16341463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561063-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16347650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1L5001A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561064-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16349458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561065-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16352320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120110</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561066-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16362691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561067-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16372476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT FORMULATION ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1L5002A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>1DF:1CAPS</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561068-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16373664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>2 TABS DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561069-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16388530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561070-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16394819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>1DF:300MG/100</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561071-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16399230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561072-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16402935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1K5067B</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>EXPOSURE TO COMMUNICABLE DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561073-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16404915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561074-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16404956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561075-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16412447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561076-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16425639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1J5005A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561077-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16425647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561078-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16432510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
        <drugdosagetext>1DF=1TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561079-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16437030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561080-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16446767</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561081-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16446809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561082-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16471419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>DOSAGE STREGTH: 200 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561083-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16472888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561084-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16481574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugdosagetext>NASAL SPRAY.</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugdosagetext>VIRAMUNE XR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>MARCH HAD TWICE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561085-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16485781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561086-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16488512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1K5066B</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561087-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16496390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT COUNTERFEIT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>105008A,1C5008A,1G5008A,1J5008A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>GEL TABLET</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561089-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16499469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561090-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16525594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561091-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16526188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>2A5005A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561092-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16529695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>T-LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A PALMITATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561093-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16530560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1K5068B</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561094-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16538985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1DF=300/200MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561095-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16541229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561096-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16547549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561097-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16551145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>TRUVADA 1 TAB DAILY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561098-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16560534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>ROUTE:OG TUBE,INCREASED TO 30 PERCENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561099-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16570335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEAR DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1DF:1 TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561100-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16577306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugdosagetext>1 DF = EPIVIR 10MG/ML 1 TEASPOONFUL.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>1 DF = 1/2 DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561101-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16577462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561102-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16584310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561103-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16607590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561104-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16618126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561105-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16618647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561106-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16624330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>2A5073A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561107-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16651515</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>1A5074A</drugbatchnumb>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>INTERRUPTED IN MAY2012 AND RESTARTED A WEEK AGO</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561108-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16673139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561109-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16673170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugindication>ACQUIRED IMMUNODEFICIENCY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugauthorizationnumb>021567</drugauthorizationnumb>
        <drugdosagetext>TABLET</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561110-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.098</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561111-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561112-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561113-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561114-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561115-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561116-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0014848</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>4.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOFYLILINE</medicinalproduct>
        <drugindication>RESPIRATORY ARREST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETANUS VACCINATION</medicinalproduct>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHTHERIA VACCINATION</medicinalproduct>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROFUMARATE</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREMATURE BABY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLIOMYELITIS VACCINATION</medicinalproduct>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHOOPING COUGH VACCINATION</medicinalproduct>
        <drugindication>IMMUNISATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561117-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BORDERLINE PERSONALITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561118-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTRAZENECA-2012SE45944</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugdosagetext>FORM STRENGTH: CANDESARTAN CILEXETIL/HCT 8/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>66</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>21093</drugauthorizationnumb>
        <drugdosagetext>FORM STRENGTH: CANDESARTAN CILEXETIL/HCT 8/12.5 MG, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561119-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRACCO-008173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>S1P115A</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTIHANCE</medicinalproduct>
        <drugbatchnumb>S1P115A</drugbatchnumb>
        <drugauthorizationnumb>021357</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ALCOHOLIC PANCREATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561120-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561121-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ABBOTT-12P-229-0929634-00</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>1 BD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROLITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSEPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>FORTNIGHTLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561122-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0950070-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIP SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>100MG OD</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111129</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561123-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ABBOTT-11P-008-0856281-00</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CUTANEOUS LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561126-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE44953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561127-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561128-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561129-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-2011002751</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MITOCHONDRIAL MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARSENIC TRIOXIDE</medicinalproduct>
        <drugauthorizationnumb>021248</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE PROMYELOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561130-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561131-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561132-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561133-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE00896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG UNK FREQUENCY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561134-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-EISAI INC-E2090-02228-SPO-DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG/KG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561135-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987783A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>189.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugdosagetext>2000MG CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5MG CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561136-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ALLERGAN-1210144US</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL TEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OZURDEX</medicinalproduct>
        <drugauthorizationnumb>022315</drugauthorizationnumb>
        <drugdosagetext>0.7 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>CYSTOID MACULAR OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561137-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007170</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561138-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16819476</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561139-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561140-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17050BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>95</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561141-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17051BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561142-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE03681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDURAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561143-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2010SE60981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561144-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE33738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>200 MG ON THE MORNING AND 600 MG ON THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>200 MG ON THE MORNING AND 600 MG ON THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561145-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17042BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561146-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-15484BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561147-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561148-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351128USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugbatchnumb>PAB14A</drugbatchnumb>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561149-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRALLY ACTING SYMPATHOMIMETICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>277058L</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561150-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120608</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ELI_LILLY_AND_COMPANY-PE201207009343</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561151-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561152-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE00968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561153-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE34986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160 MCG BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOL MED</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561154-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP038P0104</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561155-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-67802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>380101, KH042H0101</drugbatchnumb>
        <drugdosagetext>14 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101, IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561156-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP038P0104</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561157-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-67760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561158-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-59191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>KH028H0101, KH032H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>57 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561159-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561160-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561161-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561162-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-61826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL VENOUS CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP033P0101, DP031P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561163-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-65631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP014P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
        <drugtreatmentduration>1574</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561164-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561165-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-60025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP012P0101, BP088P0104, IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561166-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-CH2012-68302</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEM CELL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>15.63 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090415</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110602</drugenddate>
        <drugtreatmentduration>750</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHIONINUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100202</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BERAPROST SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCYRRHIZIC ACID, AMMONIUM SALT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100205</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561167-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2012-60363</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>5 UG, Q4HRS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561168-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2011-59676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>BP089P0103, BP 91P0103,IP014P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561169-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561170-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ACTELION-A-CH2011-49109</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERODERMA RENAL CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIGITAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561171-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561172-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ACTELION-A-JP2007-14470</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>31.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>93.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060125</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RIGHT VENTRICULAR FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061207</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061207</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSELTAMIVIR PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SILDENAFIL CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
        <drugtreatmentduration>287</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IRON DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061025</drugenddate>
        <drugtreatmentduration>272</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060117</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561173-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2011-55850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>BP086P0102, IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561174-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2012-68226</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561175-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA009PZ</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561176-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561177-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ACTELION-A-CH2012-67201</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561178-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA00ABP</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561179-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA00862</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561180-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-68207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA009PX</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561181-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA00280</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP018P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561182-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-67978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>7 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>KH041H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>8 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561183-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA000HD</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561184-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-AMGEN-ESPCT2012000532</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUIDASA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DENOSUMAB</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINOBACTIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OFARSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>74 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>111 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>740 MG, Q3WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561185-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>CALCIUM 600</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561186-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561187-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE18267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561188-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE20426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561189-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007092</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATEGLINIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561190-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007162</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUSTAZOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SP TROCHES</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561191-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE24896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED SELF-CARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561192-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVERT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD POTASSIUM ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561193-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE04683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>GENERIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561197-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19830929</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-83100014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUILLAIN-BARRE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0130</medicinalproduct>
        <drugdosagetext>30 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561198-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561199-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE77049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>17 TO 20 MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561200-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15886690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIVELLE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugdosagetext>0.1MG PATCHES ON ARMS, FEET, LEGS EXCEPT BREAST</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561201-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15941701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561202-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16402232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugdosagetext>STARTED 9 YRS AGO</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561203-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16505083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CENESTIN</medicinalproduct>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561204-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16706798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>084499</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561205-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-TEVA-330995ISR</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERMION</medicinalproduct>
        <drugindication>ABULIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMAZOLON</medicinalproduct>
        <drugdosagetext>1 GRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABULIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugdosagetext>8 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT TAB 330MG</medicinalproduct>
        <drugdosagetext>990 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>18413</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA K</medicinalproduct>
        <drugdosagetext>4 GRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>4 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561206-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007182</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561207-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561208-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE54102</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugdosagetext>2 SPRAY EACH AS REQUIRED</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561213-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120715101</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561214-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561215-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20120713722</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561216-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561217-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120714381</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESECTION OF RECTUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>HR/MIN: 16:20</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561218-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713849</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ELBOW OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAGAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHAZOLAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561219-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713631</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INFUSION#45</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561220-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713788</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICITAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561221-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713801</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561222-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713659</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FOR 52 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561223-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1200MG + 800MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070510</drugstartdate>
        <drugtreatmentduration>915</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561225-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE64627</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561226-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561227-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561228-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-LEUK-1000085</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPG 7909</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER CYTOKINES AND IMMUNOMODULATING AGENTS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK (DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK()DAY 1 AND DAY 15</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPG 7909</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER CYTOKINES AND IMMUNOMODULATING AGENTS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER CYTOKINES AND IMMUNOMODULATING AGENTS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OTHER CYTOKINES AND IMMUNOMODULATING AGENTS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPG 7909</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090623</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CPG 7909</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090611</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUKINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK(DAY 1 AND DAY 15)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090704</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561229-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-337288ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LESTAURTINIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRACURIUM BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRISENOX</medicinalproduct>
        <drugauthorizationnumb>021248</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120303</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561232-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHANOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561233-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561234-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>MH886A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561235-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111231</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710409</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugdosagetext>SINCE 10 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOBACCO ABUSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561236-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-340972USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>076135</drugauthorizationnumb>
        <drugdosagetext>51.4 MILLIGRAM; QD (M,T,R,F,SA) AND BID (W,SU)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561237-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201004003145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A840123C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A560797C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A560797C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561238-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52431</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIO DRUGS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561239-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE19272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561240-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2012SE51208</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090206</drugenddate>
        <drugtreatmentduration>717</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080711</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561241-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-EISAI INC-E2090-02028-SPO-ES</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 IN AM, 1000 MG IN PM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
        <drugtreatmentduration>114</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>3.62 MG DAILY (5 DROPS IN AM, 5 DROPS IN MID-DAY, 19 DROPS IN PM)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561242-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561243-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APLASTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561244-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ALEXION-A201201402</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugbatchnumb>A74527BP01</drugbatchnumb>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110826</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561245-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.551</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL SPINAL CORD ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESSENTIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA ENZYME SPECIFIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>0.9% FLUSH AS DIRECTED DISP SYRIN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>50 MG, QD AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN (MAPAP)</medicinalproduct>
        <drugdosagetext>325 MG, PRN 2 TABS Q4H</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE TARTRATE</medicinalproduct>
        <drugdosagetext>0.2 %, BID EACH EYE</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>10 UNIT/ML FLUSH AS DIRECTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugdosagetext>600 MG-200 TAB TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAB-A-VITE</medicinalproduct>
        <drugdosagetext>1 TAB QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISACODYL (BISAC-EVAC)</medicinalproduct>
        <drugdosagetext>10 MG, QD SUPPOSITORY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>0.5 %, BID 1 DROPP</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, PRN 1 TAB Q4H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 MEQ 2 TABS, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG, PRN 2 CAPS QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugdosagetext>400 MG/5ML GIVE 30 ML QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENEMA DISPOSABLE</medicinalproduct>
        <drugdosagetext>1 ENEMA QD</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>1 MG (2 TABS), QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugdosagetext>0.4 MG, PRN 1 TAB Q5MINUTES UP TO 3 DOSES</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN (MAPAP)</medicinalproduct>
        <drugdosagetext>NTE 3-4 GMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BODY TEMPERATURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>300 ?G, Q2W HOLD FOR HGB GREATER THAN (RECOMMEND 10)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561246-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201201421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561247-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE41967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561248-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561249-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE37610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561250-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-11P-062-0696899-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561251-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0962038-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561252-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120707188</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BESOFTEN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTEBATE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARINOID</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIDARABINE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSER</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYMESASON</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561253-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120713320</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOVONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBOXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XAMIOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETNESOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYLOPROCT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHOSYL HC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMOVATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAL TAR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON (ANTACID)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-DYDRAMOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROCODEINE BITARTRATE INJ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561254-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011252466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugauthorizationnumb>050007</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101209</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101129</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20MEQ, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
        <drugdosagetext>200 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101205</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>1 TAB, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110124</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>0 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV PERIPHERAL NEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110118</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>0 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110125</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugdosagetext>1 TAB, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561255-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100911</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185552</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>[OLMESARTAN MEDOXOMIL 20 MG/ HYDROCHLOROTHIAZIDE 12.5 MG], DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561256-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185690</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561257-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012182998</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>10 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111214</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561258-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012183528</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>20 MG, ONCE DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>[OLMESARTAN MEDOXOMIL 20 MG]/ [HYDROCHLOROTHIAZIDE 12.5MG] ONCE DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>15 MG, TWICE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, TWICE DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE DAILY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, ONCE DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561259-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-DE-01741DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULEXETIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPROZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMIZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561260-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350217USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>076135</drugauthorizationnumb>
        <drugdosagetext>40 MILLIGRAM;</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561261-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14482BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUMETZA SR</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>160969C</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561262-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AP-00614RI</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561263-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE73365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWEATING FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>300 MG AND 150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561264-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE31990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, 2 PUFFS TWICE DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561265-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CANCER IN REMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561266-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16470BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugindication>PROSTATE INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561267-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-UCBSA-062736</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUBRENZA</medicinalproduct>
        <drugauthorizationnumb>21829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugdosagetext>80/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561268-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16572BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561269-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17044BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561270-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17049BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>2 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HICCUPS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>159998A</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>360 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>20 MEQ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC PROTRUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
        <drugdosagetext>48 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>2 PUF</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUS CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAFLO</medicinalproduct>
        <drugdosagetext>8 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561271-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16668BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561272-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070611</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561273-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE49061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOROBMONO ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561274-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE57908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561275-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2012SE50334</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22751</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561276-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-JNJFOC-20120713618</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561277-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561278-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714435</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561279-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561280-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561281-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACARDIAC THROMBUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561282-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561283-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENILE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561284-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561285-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561286-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561287-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1204USA01891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-CARDIAC CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYDIPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, CYCLICAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>35 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugdosagetext>1500 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561288-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1201USA00765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040130</drugenddate>
        <drugtreatmentduration>992</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010514</drugenddate>
        <drugtreatmentduration>840</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080222</drugenddate>
        <drugtreatmentduration>1402</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100222</drugenddate>
        <drugtreatmentduration>732</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040422</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561289-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-EISAI INC-E2090-02010-SPO-ES</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRUGADA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugdosagetext>150 MG 1 IN 2 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>250 MG, 1 IN 2 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugdosagetext>100 MG 1 IN 2 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561290-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HALLUCINATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561291-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012184752</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>OLMESARTAN/HYDROCHLOROTHIAZIDE 20/12.5 MG 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561292-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012146346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561293-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561294-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE00722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>494</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561295-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561296-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007330</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBAMIPIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561297-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NAPPMUNDI-DEU-2012-0009067</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALLADONE</medicinalproduct>
        <drugauthorizationnumb>019892</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561298-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE38318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5, TWO PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561299-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561304-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207009325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERCUTANEOUS CORONARY INTERVENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561305-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207009329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561306-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207009313</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRASUGREL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>22307</drugauthorizationnumb>
        <drugdosagetext>60 MG, SINGLE</drugdosagetext>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>5000 IU, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561307-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201208000566</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561308-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0958070-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561309-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN011719</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTORAL (CHLORMADINONE ACETATE)</medicinalproduct>
        <drugdosagetext>DIVIDED DOSE FREQUENCY U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENOTROPINS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONADOTROPIN, CHORIONIC</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GANIREST SUBCUTANEOUS 0.25MG SYRINGE</medicinalproduct>
        <drugauthorizationnumb>21057</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110527</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONAPURE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONADOTROPIN, CHORIONIC</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>OVULATION INDUCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561310-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008642</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>1586</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561311-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ASTRAZENECA-2012SE41166</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMEDIATE POST-INJECTION REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561316-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-009507513-1208BRA000233</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART DISEASE CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISADOR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561317-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>NL-MEDIMMUNE-MEDI-0015006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>7.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugdosagetext>2 PUFF, 4 IN 1 DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PREMATURE BABY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYNAGIS</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561319-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-007673</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT CC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561320-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008228</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561321-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE38482</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>AC0074,,,</drugbatchnumb>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>ONE AND HALF TABLETS OF 200 MG, TOTAL DAILY DOSE 300 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>AC0074,,,</drugbatchnumb>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>ONE AND HALF TABLETS OF 200 MG, TOTAL DAILY DOSE 300 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>AC0074,,,</drugbatchnumb>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>ONE AND HALF TABLETS OF 200 MG, TOTAL DAILY DOSE 300 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugbatchnumb>AC0074,,,</drugbatchnumb>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>ONE AND HALF TABLETS OF 200 MG, TOTAL DAILY DOSE 300 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561322-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE25882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SLEEP-RELATED EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>ADRENAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN PILLS</medicinalproduct>
        <drugdosagetext>5 MG EVERY 4-6 HOUR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYE HDNA ZOPYRID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10/325 DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110428</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110428</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>2 MUSCLE RELAXANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561323-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561324-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE21516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561326-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E2020-10865-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugdosagetext>3 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL</medicinalproduct>
        <drugdosagetext>10 G</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICAMLO</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSOZYME HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>10 G</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPLEN</medicinalproduct>
        <drugdosagetext>4 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>2 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>2 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITANEURIN</medicinalproduct>
        <drugdosagetext>2 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>1 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561327-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561328-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugindication>MYELOID METAPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561329-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008786</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561330-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1102USA02524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEHCET'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY PNEUMATOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS POSTMENOPAUSAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010828</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070328</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561331-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29632</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>54.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATHEROSCLEROSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561332-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561333-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE24457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLASHBACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE AS REQUIRED</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>VARIOUS DOSAGES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>600 MG OR 800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561334-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351315USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugindication>WHEEZING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120729</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC (NOS)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MED (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561335-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0962687-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>141352E</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugdosagetext>30 MG 4 MONTH DEPOT</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561336-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ABBOTT-12P-035-0962859-00</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>130</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561337-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN062698</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALDOLASE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561338-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010FR13672</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugdosagetext>360 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>021560</drugauthorizationnumb>
        <drugdosagetext>1.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100828</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>021560</drugauthorizationnumb>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100829</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561339-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-ES-00302ES</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOCTAMID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561340-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-DE-01780DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561341-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BL-00451BL</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561342-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AU-01323AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MESENTERIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561343-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17028BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PH URINE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>90 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B SPECTRUM</medicinalproduct>
        <drugindication>METABOLIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19600101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B SPECTRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19600101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>350 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPROPRIUM BROMIDE AND ALBUTEROL SULFATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IMMUNE SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19600101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE EYE DROPS</medicinalproduct>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561344-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16265BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561345-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17007BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRONTAL SINUS OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>160969C</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG 75/25</medicinalproduct>
        <drugdosagetext>70 U</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>160969C</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561346-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00997UK</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLMITRIPTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561347-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX066531</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 160/5 MG), DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561348-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.062 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561349-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066472</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CATAFLAM</medicinalproduct>
        <drugbatchnumb>Z0317</drugbatchnumb>
        <drugauthorizationnumb>020142</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561350-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012DE009540</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>47.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561351-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17137BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561352-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17052BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561353-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16667BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561354-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CN-01650CN</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561355-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14007NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOSENN</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561356-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-RA-00195RA</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561357-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561358-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE22849</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561359-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE21846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMATOFORM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPERSONALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>150 MG EVERY MORNING AND 300 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>150 MG EVERY MORNING AND 300 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugdosagetext>150 MG EVERY MORNING AND 300 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCOTICS</medicinalproduct>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561360-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17172BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561361-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16694BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561362-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17254BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561363-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CS-01081AE</companynumb>
    <primarysource>
      <reportercountry>LEBANON</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561364-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17317YA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTRICTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE/SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCIN (INFLUENZA VACCINE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEZOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561365-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17263BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561366-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17316BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561367-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-007925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561368-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49459</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561369-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>PROPHYLAXIS URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugbatchnumb>NF2324,,,</drugbatchnumb>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561370-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE27256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>100.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>3 IN THE MORNING AND 2 AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEDRIN</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561371-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>89160</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561372-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202945</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE/ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>087463</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561373-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-CELGENEUS-114-20785-12051158</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100816</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110426</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110426</drugenddate>
        <drugtreatmentduration>245</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561374-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561375-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50489</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561376-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIBRIUM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561377-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0719241A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561378-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0724624A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>140.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561379-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0799236A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561380-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0809149A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAPULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071009</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561381-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0835777A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561382-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0844979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561383-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0849271A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060413</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561384-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0870848A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561385-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0877050A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561386-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0877051A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561387-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0883870A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060130</drugenddate>
        <drugtreatmentduration>462</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070210</drugenddate>
        <drugtreatmentduration>635</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561388-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0896835A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561389-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0899183A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070904</drugenddate>
        <drugtreatmentduration>96</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561390-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0899185A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>10MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561391-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0899187A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561392-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0899188A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561393-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0913461A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561394-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0914640A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>110.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561395-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0929980A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561396-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0933240A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561397-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0972496A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugdosagetext>125MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
        <drugdosagetext>60MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>C551020</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561398-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0976979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION FOR HIGH BLOOD PRESSURE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ANXIETY MED- NAME UNKNOWN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561399-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0980352A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STATUS ASTHMATICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>2ZP6538</drugbatchnumb>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>2PUFF FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIAL HYPERREACTIVITY</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561400-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0981410A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS EXFOLIATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS EXFOLIATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugbatchnumb>11405019A</drugbatchnumb>
        <drugauthorizationnumb>019821</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>100MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS EXFOLIATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561401-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0982628A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugbatchnumb>C518298</drugbatchnumb>
        <drugauthorizationnumb>020080</drugauthorizationnumb>
        <drugdosagetext>6MG AS REQUIRED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561402-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0986979A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL DEFAECATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>1ZP3835</drugbatchnumb>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561403-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987205A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020358</drugauthorizationnumb>
        <drugdosagetext>100MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561404-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0987275A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MALARONE</medicinalproduct>
        <drugauthorizationnumb>021078</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561405-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0987471A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugdosagetext>32.6NGK CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561406-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987580A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>M362</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugdosagetext>28U CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561407-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987585A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561408-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987590A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>420MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561409-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0987790A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugdosagetext>165MCG PER DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugdosagetext>40DROP PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561410-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987802A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUDDEN CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561411-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987809A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561412-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987810A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYCAMTIN</medicinalproduct>
        <drugauthorizationnumb>020981</drugauthorizationnumb>
        <drugdosagetext>3.5MG SEE DOSAGE TEXT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561413-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987811A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugbatchnumb>2ZP0132</drugbatchnumb>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561414-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987812A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ONCOLOGIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561415-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987813A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561416-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987814A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ONCOLOGIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugauthorizationnumb>019821</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561417-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987815A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561418-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987913A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561419-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GLAXOSMITHKLINE-A0987928A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>10DROP AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561420-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987929A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>021254</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN HFA</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561421-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987930A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugdosagetext>1TAB TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090130</drugenddate>
        <drugtreatmentduration>779</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>4MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561422-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987932A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561423-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987938A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL DIAPHRAGMATIC HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561424-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987957A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561425-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987959A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561426-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987966A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROSCHISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561427-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987968A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL ANTEVERSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561428-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987980A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561429-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-GLAXOSMITHKLINE-B0700483B</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMATISATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTIGA</medicinalproduct>
        <drugauthorizationnumb>022345</drugauthorizationnumb>
        <drugdosagetext>1050MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561430-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0741634A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROSIGLITAZONE</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561431-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0757122A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110728</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111013</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugdosagetext>1MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111215</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110519</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADONA (AC-17)</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROMIPLOSTIM</medicinalproduct>
        <drugdosagetext>50MCG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>22291</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110421</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110522</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>12.5MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110527</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110811</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561432-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0797265A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVISCOSITY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561433-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0802135A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIPROSTAT</medicinalproduct>
        <drugdosagetext>9IUAX PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561434-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0807344A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>22465</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561435-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0808366A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>200MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugdosagetext>45MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE</medicinalproduct>
        <drugauthorizationnumb>018473</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARBOCYSTEINE</medicinalproduct>
        <drugdosagetext>750MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111031</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugdosagetext>400MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>UPPER RESPIRATORY TRACT INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON</medicinalproduct>
        <drugdosagetext>45MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561436-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0810506A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100803</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100921</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100622</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>2400MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100428</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERKERATOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100629</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>3000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561437-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-GLAXOSMITHKLINE-B0811651A</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>900MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1250MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561438-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VIIV HEALTHCARE LIMITED-B0813124A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROENCEPHALOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE/LAMIVUDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021652</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019655</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561439-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ME-GLAXOSMITHKLINE-B0813547A</companynumb>
    <primarysource>
      <reportercountry>MONTENEGRO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>3489736</drugbatchnumb>
        <drugauthorizationnumb>022460</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANADOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561440-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0814536A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>50MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLONANSERIN</medicinalproduct>
        <drugdosagetext>24MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>20241</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLONANSERIN</medicinalproduct>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLONANSERIN</medicinalproduct>
        <drugdosagetext>16MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRNAMIN</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561441-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0816028A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>020548</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561442-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0816520A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTOMIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODOPIN</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>12.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>4800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAZINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>27MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR I DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561443-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GLAXOSMITHKLINE-B0816659A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN SOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTIGA</medicinalproduct>
        <drugauthorizationnumb>022345</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEBINIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561444-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0816714A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOCELLULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugauthorizationnumb>020781</drugauthorizationnumb>
        <drugdosagetext>8MG WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>25MGML WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOSTATIC HYPOTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugdosagetext>200DROP PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561445-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0816948A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTISM SPECTRUM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IDIOPATHIC GENERALISED EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561446-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0816958A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561447-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0816959A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugdosagetext>375MG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugauthorizationnumb>020983</drugauthorizationnumb>
        <drugdosagetext>2.5MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561448-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-B0818442A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugauthorizationnumb>018644</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561449-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0818467A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561450-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0818846A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>21077</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561451-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0819225A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>500MCG PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561452-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0819228A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URIEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561453-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0819402A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugdosagetext>16G PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>600MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENCEPHALITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>1.5G PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120213</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugdosagetext>3G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMONIA KLEBSIELLA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULINE</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561454-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0819551A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugdosagetext>1000MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561455-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-GLAXOSMITHKLINE-B0819747A</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADOLINIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561456-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-B0819750A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE DURING BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>021142</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>THERMAL BURN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561457-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0076533A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561458-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0076535A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>022460</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561459-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561460-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>020768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUTERA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561461-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561462-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7059271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL MOTILITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED CEREBRAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
        <drugtreatmentduration>366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561463-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003024</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561464-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>019764</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561465-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7073670</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561466-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7052810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561467-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7059228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>170</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561468-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12062379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>5 UNITS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugdosagetext>1.3 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>800 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SULFATETHIAMIN COMPOUND TAB</medicinalproduct>
        <drugdosagetext>325</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561469-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003024</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561470-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNINTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00D19</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561471-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATAZIA</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugindication>MENORRHAGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NATAZIA</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561472-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EVU</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561473-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561474-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>1952</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>1952</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561475-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1204USA01703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED CLAW TOE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILIUM FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE SUBCUTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY DYSMORPHIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULITIS LUMBOSACRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA OF LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL HEPATITIS CARRIER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
        <drugtreatmentduration>3477</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561476-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM POOR R-WAVE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEITIS DEFORMANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561477-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19960124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-96011608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19951110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561478-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOOST</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561479-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TASTE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>G009242,,,</drugbatchnumb>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561480-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHEST DISCOMFORT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561481-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1210364US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugdosagetext>200 UNITS, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561482-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861064-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OOPHORECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081106</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561483-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958745-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRECANCEROUS SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561484-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMOVO</medicinalproduct>
        <drugauthorizationnumb>022511</drugauthorizationnumb>
        <drugdosagetext>500 MG/20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561485-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561486-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561487-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-PFIZER INC-2012076601</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NONACOG ALFA</medicinalproduct>
        <drugdosagetext>2060 IU WEEKLY (1030, 2 UNITS WEEKLY)</drugdosagetext>
        <drugindication>FACTOR IX DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120207</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561488-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-001-0073-M0200107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRACHEOBRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RUPTURED CEREBRAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL FIELD DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA KLEBSIELLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC ISCHAEMIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>010151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970410</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOPAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANNITOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>(D5 1/2 NS WITH 20 MEQ KCL)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970424</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOBARBITAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPRUSSIDE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970422</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>019950</drugauthorizationnumb>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugauthorizationnumb>10151</drugauthorizationnumb>
        <drugdosagetext>1GM FOLLOWED BY 300MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>019950</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIMODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970413</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRESH FROZEN PLASMA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561489-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561490-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012158908</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI FACTOR IX ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugindication>PROTEINURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMINE CAP</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugindication>HAEMATURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS MEMBRANOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PROTEINURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HAEMATURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>884</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NONACOG ALFA</medicinalproduct>
        <drugdosagetext>2000 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS MEMBRANOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>889</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFAROL</medicinalproduct>
        <drugdosagetext>0.25 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>884</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561491-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12072501</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561492-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120705776</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561493-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120707606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561494-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120800417</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561495-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120612367</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLOPATADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561496-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561497-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561498-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM VENOUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561499-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CHOLESTEROL MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561500-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561501-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20110206953</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>HAS HAD 26 INFUSIONS TILL THE TIME OF THE REPORT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561502-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIP AND/OR ORAL CAVITY CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ON REMICADE FOR 4 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561503-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120715369</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>TREATED WITH REMICADE 4X200 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561504-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED COPD MEDICATIONS</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561505-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>FREQUENCY ^UNKNOWN^</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561506-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN000513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.317</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>15 MG AM, 5 MG PM, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>15 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561507-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19970303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-96081289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561508-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50727</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561509-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugbatchnumb>NH153,,,</drugbatchnumb>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561510-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561511-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-CELGENEUS-114-20785-12051159</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101019</drugenddate>
        <drugtreatmentduration>417</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561512-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-346459ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>076119</drugauthorizationnumb>
        <drugdosagetext>30MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSED MOOD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugdosagetext>450MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561513-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PURDUE-CAN-2012-0003216</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBSTANCE ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugauthorizationnumb>19892</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561514-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVER OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM TABLET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561515-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561516-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561517-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120706709</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugauthorizationnumb>021976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LENTIVIRUS TEST POSITIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugdosagetext>FROM ACCIDENT AND EMERGENCY, PRESCRIBED FOR 10 DAYS</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FOREIGN BODY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561518-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20120512785</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561519-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120601988</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561520-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICRONOR</medicinalproduct>
        <drugbatchnumb>1GM192</drugbatchnumb>
        <drugauthorizationnumb>016954</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561521-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALACTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>22264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561522-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAZADYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561523-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120712753</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>DAILY DOSE 90 (NO UNIT REPORTED)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561524-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120711327</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>21121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561525-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714102</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MICTURITION FREQUENCY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN IB</medicinalproduct>
        <drugbatchnumb>CMA076</drugbatchnumb>
        <drugauthorizationnumb>019012</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YEAST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOTRIN IB</medicinalproduct>
        <drugbatchnumb>CMA076</drugbatchnumb>
        <drugauthorizationnumb>019012</drugauthorizationnumb>
        <drugdosagetext>200MG/CAPLET, 2 CAPLETS, ONCE DAILY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER OIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>10/12.5 MG ONCE DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561526-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugbatchnumb>CDA001</drugbatchnumb>
        <drugauthorizationnumb>019860</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM A-D</medicinalproduct>
        <drugbatchnumb>CDA001</drugbatchnumb>
        <drugauthorizationnumb>019860</drugauthorizationnumb>
        <drugdosagetext>AS DIRECTED ON LABEL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561527-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120714212</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE TONSILLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561528-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120521378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>020634</drugauthorizationnumb>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>0.02% 0.5 MG/2.5 ML</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>0.83% 2.5 MG/ 3MI</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561529-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MILLENNIUM PHARMACEUTICALS, INC.-2012-03991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561530-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MILLENNIUM PHARMACEUTICALS, INC.-2012-05246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT PROVIDED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561531-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-C5013-12032601</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTATIC RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>2000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 MICROGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561532-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIFFERENCE OF EXTREMITIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugdosagetext>100 MG EVERY MORNING AND 50 MG EVERY NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561533-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561534-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50452</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUNTERFEIT DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561535-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-CELGENEUS-153-21880-12061323</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACERTIL</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLIKAN</medicinalproduct>
        <drugdosagetext>4 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>2 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMO</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMINE CAP</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMINE CAP</medicinalproduct>
        <drugdosagetext>2 CAP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISMO</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUACTION</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORISON</medicinalproduct>
        <drugdosagetext>4 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STROCAIN</medicinalproduct>
        <drugdosagetext>3 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPYRETIN</medicinalproduct>
        <drugdosagetext>2000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>24 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLASMANATE</medicinalproduct>
        <drugdosagetext>4 BOT</drugdosagetext>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOPRIDE</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONEFOS</medicinalproduct>
        <drugdosagetext>800 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROWN MIXTURE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAM</medicinalproduct>
        <drugdosagetext>6 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLIKAN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTATED RINGER'S</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>24 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>0.5 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMO</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMO</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALGLON</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>1 VIAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERMIN</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>1 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>10 CC</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLIKAN</medicinalproduct>
        <drugdosagetext>2 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPYRETIN</medicinalproduct>
        <drugdosagetext>2000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLUVEN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>2 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATES</medicinalproduct>
        <drugdosagetext>20 CC</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSAMINE CAP</medicinalproduct>
        <drugdosagetext>1 CAP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANTHIUM</medicinalproduct>
        <drugdosagetext>1 CAP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>10 AMP</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>10 AMP</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES SIMPLEX</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPYRETIN</medicinalproduct>
        <drugdosagetext>2000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECEDEX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECEDEX</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPTIN</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>1 BG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPYRETIN</medicinalproduct>
        <drugdosagetext>2000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLULYTE</medicinalproduct>
        <drugadministrationroute>023</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERMIN</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>3 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>2 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 AMP</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMO</medicinalproduct>
        <drugdosagetext>1 TAB</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561536-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL PROLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEGA-3-ACID ETHYL ESTERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>3285</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561537-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561538-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561539-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>REGURGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561540-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-50794-12080109</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMELTEON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMMETREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561541-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ABBOTT-12P-035-0962866-00</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>807086</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561542-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0962606-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20517</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DURING HOSPITALIZATION, 2 DOSES</drugdosagetext>
        <drugindication>CHEST DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561543-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-347021ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOREFLEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IOMERON-150</medicinalproduct>
        <drugindication>IMAGING PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>075297</drugauthorizationnumb>
        <drugdosagetext>150 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561544-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17045BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561545-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-RD-00363EU</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONINEZUUR [BISPHOSPHONATE]</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANETTE CREME</medicinalproduct>
        <drugdosagetext>2 UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN EXFOLIATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>400 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI 1356</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBINE MONONITRAAT</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOL CREME</medicinalproduct>
        <drugdosagetext>2 UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN EXFOLIATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561546-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561547-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE41771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVISTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561548-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG-ZMT</medicinalproduct>
        <drugauthorizationnumb>021231</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561549-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2012-RO-01624RO</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>80352</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561550-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16977BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561551-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120712002</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561552-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL ERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOMICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PROLACTIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSYCHIATRIC SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561553-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00F5Z</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561554-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB063282</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077040</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561555-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB066449</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS NECROTISING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>077766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>437</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120330</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561556-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR063256</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMAN HERPESVIRUS 7 INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>064076</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561557-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB065985</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>091198</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561558-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR065404</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugauthorizationnumb>070889</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561559-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2012DE002453</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>076969</drugauthorizationnumb>
        <drugdosagetext>47.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561560-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB055514</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWEAT GLAND DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>12.5 UG, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>SPINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>075539</drugauthorizationnumb>
        <drugdosagetext>900 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561561-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012FR007477</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugdosagetext>110 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110723</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugdosagetext>17.15 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110723</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugdosagetext>4.4 G, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110723</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>167 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>104 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASFON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561562-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA064477</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARADOXICAL DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRIDOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFAMPICIN</medicinalproduct>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugauthorizationnumb>008662</drugauthorizationnumb>
        <drugdosagetext>12 MG/KG/DAY</drugdosagetext>
        <drugindication>PULMONARY TUBERCULOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561563-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BE043112</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>075757</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY, ABOUT 20 DAYS PER MONTH</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>075757</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID, ABOUT 10 DAYS PER MONTH</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561564-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB065476</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>090029</drugauthorizationnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561565-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB066308</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40196</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugdosagetext>5 ML</drugdosagetext>
        <drugindication>ORAL CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXIDO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561566-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP049254</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE INTERSTITIAL PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RALES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>201525</drugauthorizationnumb>
        <drugindication>ADENOSQUAMOUS CELL LUNG CANCER STAGE IV</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561567-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN062642</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>079206</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561568-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP050819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>078812</drugauthorizationnumb>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugauthorizationnumb>78812</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>COLON CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561569-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR057607</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>14 DF, QMO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>064076</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTACARINAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561570-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GXKR2012DE002463</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEGAKARYOCYTES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugauthorizationnumb>078015</drugauthorizationnumb>
        <drugdosagetext>0.4 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561571-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008812</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISULASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561572-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-FRI-1000026506</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>022522</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST (DOUBLE-BLIND)</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561573-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008815</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAC-B</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVAMYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561574-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-CELGENEUS-028-C5013-12053306</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>650 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>330 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UREMOL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561575-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2003038614</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELDOX (CAPSULES)</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030911</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561576-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>5,000 UNITS TWICE DAILY</drugdosagetext>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>650 MG, 4X/DAY, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>3.125 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>30 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>15 MG, AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>1 G, 1X/DAY</drugdosagetext>
        <drugindication>SEPSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugauthorizationnumb>21131</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL</medicinalproduct>
        <drugdosagetext>675 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK, ONCE DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTOBACILLUS ACIDOPHILUS</medicinalproduct>
        <drugdosagetext>2 DF, 2X/DAY</drugdosagetext>
        <drugindication>CLOSTRIDIAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>600 MG, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE</medicinalproduct>
        <drugdosagetext>2 PUFFS FOUR TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE</medicinalproduct>
        <drugdosagetext>0.125 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>800 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561577-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>FOUR TIMES PER WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561578-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48838</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugindication>RENAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugbatchnumb>NI2348,,,</drugbatchnumb>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561579-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>2928</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561580-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012697</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561581-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561582-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561583-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561584-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORCHITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561585-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351072USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561586-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561587-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-008930</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHARANTHINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561588-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-062810</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTICONVULSANT DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES WITH SECONDARY GENERALISATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES WITH SECONDARY GENERALISATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARTIAL SEIZURES WITH SECONDARY GENERALISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561589-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE45703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugdosagetext>32 MCG, TWO SPRAYS DAILY PRN</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561590-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561591-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561592-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057104</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561593-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>19810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561594-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOSS OF LIBIDO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561595-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561597-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GENZYME-CLOF-1002226</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561598-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561599-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>2196</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>2196</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561600-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1203USA03479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUPUYTREN'S CONTRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOIDECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODAL ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>5110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561601-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561602-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>3000434C0,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, TWO PUFFS, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugbatchnumb>,,,</drugbatchnumb>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, ONE PUFF, TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561603-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE42915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561608-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49433</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561609-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561610-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561611-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR062769</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9MG/5CM2, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561612-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561613-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugauthorizationnumb>021093</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561615-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>019888</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561620-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120604309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561621-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>812</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561622-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561623-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1108USA01141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70/5600</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100324</drugenddate>
        <drugtreatmentduration>807</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080108</drugenddate>
        <drugtreatmentduration>2535</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010130</drugenddate>
        <drugtreatmentduration>1649</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561624-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugdosagetext>180 MCG, TWO INHALATION IN AM AND ONE IN PM</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561625-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351323USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZILECT</medicinalproduct>
        <drugauthorizationnumb>021641</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561626-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561627-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17041BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561628-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-RD-00365EU</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOL CREME</medicinalproduct>
        <drugdosagetext>2 UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN EXFOLIATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBINE MONONITRAAT</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONINEZUUR [BISPHOSPHONATE]</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANETTE CREME</medicinalproduct>
        <drugdosagetext>2 UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>SKIN EXFOLIATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI 1356</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>400 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561629-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2011-BP-15728BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561630-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-EU-03768GD</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugauthorizationnumb>020938</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561631-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROXANE LABORATORIES, INC.-2012-EU-02480GD</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMEMBRANOUS COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION ENTEROCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY MUSCLE WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>DOUBLE STRENGTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAMIDINE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>800 MG</drugdosagetext>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>250 MG</drugdosagetext>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>84122</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>CHRONIC GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PNEUMOCYSTIS JIROVECI PNEUMONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561632-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>CA1527A</drugbatchnumb>
        <drugdosagetext>UNK UNK, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561636-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPENDENT PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MERYCISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561637-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561638-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugdosagetext>0.25 MG IN 2 ML, DAILY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561639-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GILEAD-2012-0059029</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVARY GLAND CALCULUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>21937</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561640-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2012-0056921</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>22081</drugauthorizationnumb>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARELOAD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561641-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060901</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561642-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CLONIC MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATELLA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA PRIMARY ATYPICAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561643-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351074USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugauthorizationnumb>021875</drugauthorizationnumb>
        <drugdosagetext>250 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561644-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FLUMAX</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561645-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0963046-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020708</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561646-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561647-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE40832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>20.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTUSSUSCEPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561653-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-348511USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561654-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE42413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561655-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugdosagetext>SAME DOSE IN THE MORNING AND AT NOON AND MORE AT NIGHT TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561656-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ULCER HAEMORRHAGE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561657-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20090801237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>2925 MG PER DAY,1 YEAR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561658-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20051105112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561659-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>40 MG, AT 12:00 HE TOOK 2 NEXIUM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561660-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561661-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561664-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561665-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugdosagetext>ONE PUFF EACH MORNING</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561666-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52075</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561667-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561668-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561669-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561670-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561671-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561672-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561673-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561674-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561675-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561676-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561677-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561678-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561679-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CAVITY CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561680-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAXTER-2012BAX013073</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>S34P7</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561681-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561682-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561683-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>C867929</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>C871590</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>C867804</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561684-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561685-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561686-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561687-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-057064</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE :1 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOCHU-EKKI-TO</medicinalproduct>
        <drugdosagetext>DAILY DOSE : 22.5 GM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALTOPROFEN</medicinalproduct>
        <drugdosagetext>DALY DOSE :80 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>504</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 1 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 50 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY DOSE : 10MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE :25 MG AS REQURED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>294</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARPOGRELATE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE :300 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>839</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>646</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>436</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>275-08-003:200 MG ONCE IN 2 WEEKS + 400 MG ONCE EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugdosagetext>DAILY DOSE :100 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE :2.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>849</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561688-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHIECTASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561689-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2009SP021058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561690-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561691-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561692-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561693-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561694-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>50 MG, Q12H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>073288</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561695-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2012-0051456</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PHOSPHORUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>100MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPSERA</medicinalproduct>
        <drugauthorizationnumb>021449</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>5MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugdosagetext>300MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARACLUDE                          /03597801/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561696-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-UCBSA-062743</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>50MG DAILY FOR 2 DAYS AND THEN STOPPED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>21035</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561697-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0963049-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019732</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561698-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARDIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561699-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0055826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561700-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROXANE LABORATORIES, INC.-2012-RO-01607RO</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>076904</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561701-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-15057NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561702-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX009822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561703-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561704-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561705-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011745</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561706-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX012985</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561707-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561708-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX011315</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561709-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561710-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561711-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011241</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561712-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2011BH040400</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012141</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012141</drugauthorizationnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOKINES AND IMMUNOMODULATORS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POLYNEUROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561713-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561714-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561715-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-BAXTER-2012BAX012996</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CECON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561716-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX013239</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 1.5% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561717-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX013232</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUTRINEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561718-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX010031</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561719-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561720-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561721-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2012BAX010598</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCLEROSING ENCAPSULATING PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENVELA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRLECIT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10MG/2ML</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEKRISTOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPIRTINE MALEATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANSTEC PRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIONEAL 40 GLUCOSE 3,86 % W/V 38,6 MG/ML PERITONEALDIALYSELOSUNG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIONEAL 40 GLUCOSE 2,27 % W/V 22,7 MG/ML PERITONEALDIALYSELOSUNG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTIMEL COMPACT CAPPUCCI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITARENAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561722-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX012983</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561723-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX008142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561724-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561725-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561726-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561727-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2012BAX012930</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>012142</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561728-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX012986</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 1.5% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561729-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561730-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2012BAX009263</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROPERIDOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUPRANE</medicinalproduct>
        <drugbatchnumb>H167K131</drugbatchnumb>
        <drugauthorizationnumb>20118</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPHEDRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPHEDRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOSTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MAINTENANCE OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPIVACAINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PICILLIBACTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUGAMMADEX SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>ANAESTHESIA REVERSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>040</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCURONIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURBIPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561731-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561732-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561733-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC GASTROPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561734-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561735-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0054822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TUMS                               /00193601/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561736-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-CELGENEUS-144-C5013-12070321</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>80 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561737-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugauthorizationnumb>020929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561738-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561739-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561740-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR065471</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>075985</drugauthorizationnumb>
        <drugdosagetext>850 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561741-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER MEDICINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT FLEXHALER</medicinalproduct>
        <drugbatchnumb>NI2347,,,</drugbatchnumb>
        <drugauthorizationnumb>021949</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561742-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561743-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561744-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12041616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOTIC MICROANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POST HERPETIC NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugindication>AMYLOIDOSIS</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AMYLOIDOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561745-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ALLERGAN-1210333US</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OZURDEX</medicinalproduct>
        <drugbatchnumb>534009 4940711 810538300</drugbatchnumb>
        <drugauthorizationnumb>022315</drugauthorizationnumb>
        <drugdosagetext>0.7 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>031</drugadministrationroute>
        <drugindication>RETINAL VEIN OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561746-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAXTER-2012BAX012522</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE MAGNESIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE 125</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>2010710524</drugbatchnumb>
        <drugauthorizationnumb>16677</drugauthorizationnumb>
        <drugdosagetext>1 UNIT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>1F059A</drugbatchnumb>
        <drugdosagetext>1  UNIT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>112516</drugbatchnumb>
        <drugdosagetext>1 UNIT</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561747-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561748-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561749-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43318</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561750-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-UCBSA-062741</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCADIAN RHYTHM SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL SPHINCTER ATONY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>TOTAL DAILY DOSE: 4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugindication>CEREBRAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561751-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561752-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MY-CELGENEUS-101-21880-12052641</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561753-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ABBOTT-12P-020-0962108-00</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>11228LX01</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORNOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561754-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561755-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561756-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE43346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561757-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-20785-12072891</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2.25 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>20785</drugauthorizationnumb>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561758-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-BAXTER-2012BAX010849</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>11J17G10</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GESTODENE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINACALCET HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPSAMAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>12C14G40</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561759-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012627</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561760-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561761-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561762-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX009613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561763-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2012BAX012526</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MARASMUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 4.25%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561764-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX000366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>L5B9770</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561765-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012IN009718</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIOVAS</medicinalproduct>
        <drugdosagetext>10 OD</drugdosagetext>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>10 OD</drugdosagetext>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE W/METFORMIN</medicinalproduct>
        <drugdosagetext>2 OD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECOSPRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>CARDIOVASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>0.25 OD</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugauthorizationnumb>40481</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYTOR</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYTOR</medicinalproduct>
        <drugdosagetext>20 1/2 BID</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561766-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012ES051193</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JARISCH-HERXHEIMER REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>065032</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING FEVER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561767-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-FRI-1000037528</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561768-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561769-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351616USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROPROTECTANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugdosagetext>75 OR 100MG/M2 (DAY 1 AND 2 OF EA CYCLE)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>325 MILLIGRAM;</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>5 OR 10MG (DAILY,DAYS 1-21 OF EA CYCLE)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561770-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA02462</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTONIC BLADDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELLS URINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIACALCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030421</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070705</drugenddate>
        <drugtreatmentduration>763</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100405</drugenddate>
        <drugtreatmentduration>761</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060821</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030717</drugenddate>
        <drugtreatmentduration>668</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080130</drugenddate>
        <drugtreatmentduration>1006</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS (UNSPECIFIED)</medicinalproduct>
        <drugindication>LICHEN SCLEROSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081117</drugenddate>
        <drugtreatmentduration>799</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561771-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1201USA02283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCIPITAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLEX PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561772-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2010S1019330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugdosagetext>QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>QID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561773-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2011-0037861</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SALMONELLA SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CASTLEMAN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>21752</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100207</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100121</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100126</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100207</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>873</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100207</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100131</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561774-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-FRI-1000037521</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK HYPOGLYCAEMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561775-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561776-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1092298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561777-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561778-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1042317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.094</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N76810,N70196,N66082,700418,N76809,</drugbatchnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N76810,N70196,N66082,700418,N76809,</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>N76810,N70196,N66082,700418,N76809,</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>1-2 PUFFS</drugdosagetext>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10-325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>10/325</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561779-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN A DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID HORMONE-RELATED PROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOTENSIN CONVERTING ENZYME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>084912</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1000 MG (EQUIVALENT TO 400 MG OF ELEMENTAL CALCIUM/TABLET)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESIPRAMINE</medicinalproduct>
        <drugdosagetext>75 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG,FOUR TIMES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>0.25 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 U, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561780-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>250*2</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>*2</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561781-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561782-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010200</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>30 IU, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561783-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561784-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-009507513-2012SP013859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOCEPREVIR</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>2400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0805</medicinalproduct>
        <drugdosagetext>UPDATE(16APR2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561785-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-0604USA03108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANTLE CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANIMAL SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL TORUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE MORPHOLOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFUSE LARGE B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020708</drugenddate>
        <drugtreatmentduration>987</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060403</drugenddate>
        <drugtreatmentduration>2555</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561786-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-FRI-1000036987</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETAS</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>YOKUKAN-SAN</medicinalproduct>
        <drugdosagetext>5 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT OD</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561787-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096035</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>500/50</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561788-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-ROCHE-1095367</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugbatchnumb>4577</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>B6130</drugbatchnumb>
        <drugdosagetext>LAST DOSE PROIR TO SAE WAS ON 28/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561789-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2011-BP-22071BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESVERATROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COL-RITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAECES HARD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAECES HARD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION NOT FURTHER SPECIFIED</medicinalproduct>
        <drugindication>FAECES HARD</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>40 MEQ</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLON HEALTH</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROBIOTIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561790-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561791-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561792-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>500</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561793-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS SEASONAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561794-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE320197</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.178</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S0078A,S0078B,S0079,S0</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S0078A,S0078B,S0079,S0</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AIROMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S0078A,S0078B,S0079,S0</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S0078A,S0078B,S0079,S0</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED,S0078A,S0078B,S0079,S0</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REACTINE (CANADA)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561795-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US012772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERDIEM FIBER THERAPY</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561796-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012AR011095</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>2.5 MG/ DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>DOUBLE BLIND</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561797-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAEVUS FLAMMEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>1 TO 2 TABLETS ONCE OR TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19600101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561798-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US013368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561799-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB064430</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>400 UG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561800-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOFLEX ANALGESIC CREME</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOFLEX ANALGESIC CREME</medicinalproduct>
        <drugdosagetext>UNK, ON AND OFF</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG THERAPY NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK, EVERY NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561801-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ANAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugauthorizationnumb>022122</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561802-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016085</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESENEX ANTIFUNGAL</medicinalproduct>
        <drugbatchnumb>25980901</drugbatchnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HYPERHIDROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19620101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561803-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS RS LIQ COOL MINT</medicinalproduct>
        <drugdosagetext>UNK, QH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS RS LIQ COOL MINT</medicinalproduct>
        <drugbatchnumb>10021805</drugbatchnumb>
        <drugdosagetext>A BIG SLUG FROM THE BOTTLE EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561804-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016123</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOFLEX ANALGESIC CREME</medicinalproduct>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>MUSCLE SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK, QPM</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561805-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US013034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10103908</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10087498</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561806-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN TENSION HEADACHE CAPLETS</medicinalproduct>
        <drugdosagetext>1 DF, AT NIGHT, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN PM CAPLETS</medicinalproduct>
        <drugbatchnumb>10110280</drugbatchnumb>
        <drugdosagetext>2 DF, AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVIST</medicinalproduct>
        <drugindication>SNEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRAMAMINE                               /NEZ/</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>MOTION SICKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPRAZOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN TENSION HEADACHE CAPLETS</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAVIST</medicinalproduct>
        <drugdosagetext>1 OR 2 DF, A DAY</drugdosagetext>
        <drugindication>RHINORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561807-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER STICK PACKS</medicinalproduct>
        <drugbatchnumb>10110201</drugbatchnumb>
        <drugdosagetext>1 SPOONFUL DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HAEMORRHOIDS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561808-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US014719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugdosagetext>UNK, 4-5 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561809-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KE-GILEAD-2012-0057944</companynumb>
    <primarysource>
      <reportercountry>KENYA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA HAEMOLYTIC AUTOIMMUNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
        <drugtreatmentduration>1008</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561810-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOTAL LUNG CAPACITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561811-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUCOUS MEMBRANE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561812-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561813-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-009507513-1208BRA000170</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER FEMALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTRAINDICATION TO MEDICAL TREATMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVESTRION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OVESTRION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561814-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011053</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561815-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCOLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>4-5 TIMES A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>BURST (3 TIMES THIS YEAR)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561816-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561817-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561818-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561819-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>5 DF, UNK</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561820-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561821-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561822-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561823-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561824-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561825-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS SEASONAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561826-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51188</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561827-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561828-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE40892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561829-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1092736</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561830-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1038363</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090520</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>344MG-360MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>336MG-352MG</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080822</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561831-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE280883</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C,S0078A,S0078,S0065,S0077A,S0</drugbatchnumb>
        <drugdosagetext>300 MG, 1/MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C,S0078A,S0078,S0065,S0077A,S0</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C,S0078A,S0078,S0065,S0077A,S0</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C,S0078A,S0078,S0065,S0077A,S0</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C,S0078A,S0078,S0065,S0077A,S0</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C,S0078A,S0078,S0065,S0077A,S0</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0072C,S0078A,S0078,S0065,S0077A,S0</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561832-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561833-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561834-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1096066</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561835-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012032021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561836-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040649</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561837-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012023333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029712</drugbatchnumb>
        <drugdosagetext>50 MG/ML, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561838-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561839-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561840-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561841-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561842-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE44390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>80 MCG/4.5 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561843-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093999</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE AIRWAYS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEAK EXPIRATORY FLOW RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>500/50</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561844-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS RS LIQ SMTHCHERRY</medicinalproduct>
        <drugdosagetext>UNK, EVERY NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561845-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1089823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561846-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561847-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012034041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER DISSEMINATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561848-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.05</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030089</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 UNK, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561849-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561850-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561851-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012029061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561852-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012031783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561853-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012032539</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561854-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEETH BRITTLE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026595</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561855-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012031296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561856-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012015137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029704</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561857-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561858-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012032875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029703</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561859-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012013811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561860-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561861-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012033419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>76</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK 6 PILLS WEEKLY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561862-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561863-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE267947</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.071</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED BRONCHIAL SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOBRAMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>S0055B,S0078A,NOT REPORTED,NOT REPO</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>S0055B,S0078A,NOT REPORTED,NOT REPO</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOTRIMEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>S0055B,S0078A,NOT REPORTED,NOT REPO</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMOZYME</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>S0055B,S0078A,NOT REPORTED,NOT REPO</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>S0055B,S0078A,NOT REPORTED,NOT REPO</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>S0055B,S0078A,NOT REPORTED,NOT REPO</drugbatchnumb>
        <drugdosagetext>375 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEREVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMALIZUMAB</medicinalproduct>
        <drugbatchnumb>S0055B,S0078A,NOT REPORTED,NOT REPO</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561864-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012036364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY MYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561865-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012024940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030092</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561866-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012038352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>126.98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561867-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012021049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028720</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561868-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012031740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561869-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561870-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012014669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOVONEX</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLACTIN</medicinalproduct>
        <drugdosagetext>BID</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561871-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561872-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012034551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.061</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561873-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561874-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012036882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561875-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561876-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012028676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561877-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012036461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561878-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012034653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028229</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561879-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012026870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561880-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-1012570</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LAST INJECTION WAS ON 02 JANUARY 2012</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULFATE AUTOHALER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111031</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>12/400 UG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561881-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561882-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011023421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561883-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011055976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561884-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011011920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.667</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS                           /90003601/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561885-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012018893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561886-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012023962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029299</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120414</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561887-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011019380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561888-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023547</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>AUTOIMMUNE HEPATITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561889-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012028738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561890-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011036380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>29.478</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN                            /00003801/</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024380</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561891-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012035379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561892-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.517</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100720</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561893-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011059535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111230</drugenddate>
        <drugtreatmentduration>94</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561894-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011058055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.703</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561895-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012035967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561896-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>111</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023548</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561897-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012003102</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561898-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011053556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>5 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.5 ML, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561899-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011064208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028719</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>6 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561900-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011019847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021302</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561901-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012005582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561902-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE46675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561903-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE42153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>74.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHINOCORT</medicinalproduct>
        <drugauthorizationnumb>020746</drugauthorizationnumb>
        <drugdosagetext>64 MCG 1 SPRAY DAILY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561904-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561905-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110317</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561906-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12052599</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HUMAN CHORIONIC GONADOTROPIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>75 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561907-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-FRI-1000037409</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALDALIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREVISCAN</medicinalproduct>
        <drugdosagetext>10MG ALTERNATING WITH 5MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugauthorizationnumb>21742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561908-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-FRI-1000037527</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561909-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120613217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHROSCOPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561910-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-JNJFOC-20120800488</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561911-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120614759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>148.33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561912-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010004846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561913-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011007748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020320</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561914-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011065182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024944</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561915-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012003328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS EROSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110310</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561916-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561917-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011017106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.039</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE AND MOUTH X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>800 MUG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561918-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561919-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011017330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT RANGE OF MOTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, QMO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023547</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110513</drugenddate>
        <drugtreatmentduration>67</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561920-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011020350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023545</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561921-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.878</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020938</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>99 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561922-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BG-CELGENEUS-022-21880-12063253</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILGAMMA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROMITHEXANE</medicinalproduct>
        <drugdosagetext>800 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELECTROLYTE INFUSIONS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>80 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>1000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>2 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120602</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561923-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5 MCG, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561924-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE22632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561925-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561926-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-11P-028-0874355-01</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-AMILZIDE</medicinalproduct>
        <drugdosagetext>50/5</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugdosagetext>1-2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561927-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-ABBOTT-12P-216-0960671-00</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICOBRACHIAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESTIBULAR NEURONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF FALLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTONOMIC NERVOUS SYSTEM IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLOKOZA (GLUCOSE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VESTIBULAR NEURONITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561928-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953097-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANUSOL</medicinalproduct>
        <drugdosagetext>AS NEEDED TWICE DAILY</drugdosagetext>
        <drugindication>HAEMORRHOIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHACARBAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN STARTING DOSE</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561929-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0962978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561930-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20060112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2005CA05574</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>40 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561931-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAXTER-2012BAX012906</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561932-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020163</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561933-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX009977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020163</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020163</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561934-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAXTER-2012BAX012891</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEIBA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>090701</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROCOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561935-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX008553</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561936-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX011311</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM WITH DEXTROSE 1.5% AND CALCIUM 2.5MEQ/L</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561937-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-BAXTER-2012BAX013241</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561938-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HR-BAXTER-2012BAX012548</companynumb>
    <primarysource>
      <reportercountry>CROATIA (local name: Hrvatska)</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONEAL DIALYSIS COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561939-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561940-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561941-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012839</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE EAR EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561942-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020163</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561943-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561944-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561945-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013146</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXTERONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>22325</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXTERONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022325</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXTERONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022325</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UP TO 10 UG/MIN</drugdosagetext>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UP TO 100 UG/MIN</drugdosagetext>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOPRESSIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561946-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561947-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-BAXTER-2012BAX012544</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHYSIOSOL IN PLASTIC CONTAINER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561948-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010SG80842</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111008</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561949-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080630</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2008CZ043985</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>12 UG, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561950-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120713787</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561951-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120514146</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugauthorizationnumb>22304</drugauthorizationnumb>
        <drugdosagetext>50 MG THRICE IN A DAY (TID)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>SSRI (SELECTIVE SEROTONIN REUPTAKE INHIBITOR)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>90 (UNIT UNSPECIFIED) QD (EVERY DAY)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZELASTINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugauthorizationnumb>017821</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>10 (UNIT UNSPECIFIED)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561952-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA OF EYELID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561953-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugauthorizationnumb>020838</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561954-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE48879</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561955-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC GASTROINTESTINAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561956-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012833</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561957-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561958-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2012BAX012993</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFUROXIME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561959-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX009231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561960-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX010986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561961-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20061108</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2006CA009471</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561962-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE49393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED WORK ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugauthorizationnumb>019962</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561963-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011US37474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABELLED DRUG-FOOD INTERACTION MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>481</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561964-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP063255</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG, DAILY</drugdosagetext>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110910</drugenddate>
        <drugtreatmentduration>786</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561965-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561966-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561967-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561968-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561969-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561970-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561971-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561972-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030092</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561973-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561974-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030089</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561975-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028229</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561976-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL PULP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561977-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561978-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561979-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561980-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561981-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561982-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040875</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561983-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561984-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561985-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561986-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024947</drugbatchnumb>
        <drugdosagetext>25 MG, UNK, EVERY 5 TO7 DAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561987-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561988-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL WALL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561989-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561990-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030737</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561991-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561992-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561993-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561994-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561995-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561996-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561997-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561998-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8561999-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562000-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030761</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562001-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562002-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028721</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562003-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562004-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562005-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562006-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562007-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562008-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562009-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562010-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562011-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562012-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562013-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562014-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562015-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562016-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027445</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562017-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562018-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562019-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562020-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562021-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562022-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562023-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562024-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562025-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562026-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562027-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYVASO</medicinalproduct>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>1366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562028-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2012-0058134</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUCINE AMINOPEPTIDASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIART</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>22081</drugauthorizationnumb>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>1.25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562029-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARNOLD-CHIARI MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL HYDROCEPHALUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562030-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040880</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562031-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562032-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562033-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562034-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562035-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562036-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562037-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562038-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562039-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030084</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562040-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>2368</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562041-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029315</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562042-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562043-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029707</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562044-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BIOPSY SKIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027781</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562045-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562046-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562047-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562048-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, EVERY 7 TO 10 DAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562049-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562050-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562051-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562052-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562053-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562054-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562055-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562056-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025161</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562057-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029705</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562058-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562059-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562060-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562061-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562062-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562063-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562064-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030087</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562065-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562066-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562067-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562068-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562069-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562070-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562071-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562072-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>929</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562073-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562074-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562075-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562076-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011014607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023545</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562077-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONONUCLEOSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562078-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562079-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562080-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042300</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562081-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562082-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028241</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562083-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1082</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562084-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAND-FOOT-AND-MOUTH DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562085-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1043261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562086-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562087-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562088-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562089-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562090-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, EVERY OTHER WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562091-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562092-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562093-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562094-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562095-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562096-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562097-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562098-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562099-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562100-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGEMINAL NEURALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562101-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562102-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562103-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562104-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562105-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562106-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562107-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562108-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562109-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562110-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562111-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562112-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562113-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562114-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041981</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562115-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562116-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029706</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562117-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562118-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562119-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562120-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562121-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041979</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562122-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562123-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562124-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562125-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562126-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>671</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562127-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030089</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562128-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562129-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042008</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562130-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029715</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562131-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562132-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041987</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562133-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562134-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562135-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562136-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562137-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025161</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562138-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562139-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562140-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562141-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562142-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562143-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>SACROILIITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562144-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562145-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562146-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562147-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562148-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042278</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562149-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562150-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562151-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562152-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562153-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042141</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562154-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042298</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030737</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562155-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562156-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562157-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562158-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA03369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562159-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562160-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562161-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031848</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562162-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562163-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALVEOLAR OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562164-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562165-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562166-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027441</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562167-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-OPCR20121374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>201655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>201655</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>201655</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>040434</drugauthorizationnumb>
        <drugdosagetext>30/975 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562168-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562169-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562170-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562171-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562172-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562173-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562174-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562175-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562176-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562177-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562178-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC NECK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562179-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562180-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562181-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562182-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031286</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 ML, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562183-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042681</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562184-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562185-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042584</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562186-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>407</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562187-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>1277</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562188-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562189-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562190-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562191-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562192-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562193-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562194-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042388</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562195-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562196-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562197-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562198-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562199-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042567</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562200-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562201-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL318172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025529</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>22 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>P118869</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562202-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029703</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562203-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562204-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562205-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
        <drugtreatmentduration>708</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562206-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562207-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042766</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562208-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562209-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562210-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562211-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562212-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562213-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>5 PILLS EVERY WEEK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562214-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562215-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562216-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
        <drugtreatmentduration>2471</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562217-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562218-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562219-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562220-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562221-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG ONCE IN 10 DAYS</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562222-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028241</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562223-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562224-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562225-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562226-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026667</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562227-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>1 MG, TWICE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562228-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562229-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562230-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562231-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021298</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7.5 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZTIA XT</medicinalproduct>
        <drugdosagetext>360 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugdosagetext>0.05 %, Q12H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRISDOL</medicinalproduct>
        <drugdosagetext>50000 IU, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>50000 IU, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>0.1 %, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562232-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562233-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018610</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562234-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031289</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562235-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562236-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562237-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562238-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LICHEN PLANUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562239-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100311</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562240-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562241-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030759</drugbatchnumb>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562242-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562243-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562244-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562245-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042799</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562246-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562247-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562248-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562249-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562250-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562251-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031286</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562252-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562253-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562254-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562255-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562256-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042946</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562257-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562258-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562259-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562260-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562261-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>HEART DISEASE CONGENITAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>PULMONARY VEIN STENOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>TRISOMY 21</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562262-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562263-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562264-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562265-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562266-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562267-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562268-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562269-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562270-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562271-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029706</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562272-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562273-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043650</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562274-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562275-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562276-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562277-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562278-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026428</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562279-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562280-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043218</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>363</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562281-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562282-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043765</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR II DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562283-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562284-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562285-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562286-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562287-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562288-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562289-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562290-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562291-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562292-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043355</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562293-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562294-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562295-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043213</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562296-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562297-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562298-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562299-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562300-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562301-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031288</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562302-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562303-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562304-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562305-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562306-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562307-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562308-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562309-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562310-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562311-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562312-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030296</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562313-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562314-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562315-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043648</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021465</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562316-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562317-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562318-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562319-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562320-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562321-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030737</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562322-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562323-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562324-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562325-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562326-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043716</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562327-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562328-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DRYNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562329-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JUVENILE ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562330-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
        <drugtreatmentduration>663</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562331-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562332-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562333-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562334-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562335-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562336-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043667</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562337-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029185</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562338-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562339-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562340-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562341-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028485</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562342-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14896BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSOLOSIN</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562343-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011023334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562344-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>UNEVALUABLE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562345-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562346-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012001391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, ONCE IN TWO WEEKS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562347-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562348-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562349-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562350-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562351-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011033719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025521</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562352-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562353-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0962094-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562354-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960113-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562355-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562356-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043658</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.8 ML, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562357-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562358-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562359-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043746</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562360-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022276</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562361-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562362-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562363-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562364-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562365-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562366-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562367-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562368-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043713</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHEELCHAIR USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562369-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029716</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562370-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562371-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-8053521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562372-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562373-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028486</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562374-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562375-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562376-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011034151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.458</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>282</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562377-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562378-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011020712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562379-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040642</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562380-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562381-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562382-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562383-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562384-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028486</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562385-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562386-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562387-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562388-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562389-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562390-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562391-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562392-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040789</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030092</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562393-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040770</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
        <drugtreatmentduration>3843</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562394-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028209</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562395-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562396-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VARICELLA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562397-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028485</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562398-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562399-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040861</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562400-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562401-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031336</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562402-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012035328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562403-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE46351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562404-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562405-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN-D 24 HOUR</medicinalproduct>
        <drugbatchnumb>2DCS8</drugbatchnumb>
        <drugauthorizationnumb>020470</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562406-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012033466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030090</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562407-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011020388</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023547</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110327</drugenddate>
        <drugtreatmentduration>349</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562408-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011054685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029706</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562409-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012020583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028209</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562410-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562411-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012038728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562412-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011042469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025673</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562413-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011065179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.667</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED CELL DISTRIBUTION WIDTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYNACIRC</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C                          /00008001/</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK UNK, QHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A D</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA                          /00340701/</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027781</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562414-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562415-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023545</drugbatchnumb>
        <drugdosagetext>40 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562416-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011007911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022705</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562417-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011006243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022443</drugbatchnumb>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562418-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011065137</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.306</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027446</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562419-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011025304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562420-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562421-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER ORIGINAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562422-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-074834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562423-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120707</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012020275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562424-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011060988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QMO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562425-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011048988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562426-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011048806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026666</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562427-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012028651</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562428-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011061693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562429-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.748</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON M10</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGENS ESTERIFIED W/METHYLTESTOSTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018841</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562430-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011057011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026342</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562431-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012025061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OTORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029703</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120405</drugenddate>
        <drugtreatmentduration>188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562432-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011004610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020836</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562433-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011007693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACID REDUCER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022707</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562434-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>163.27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562435-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012038950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028229</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562436-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021468</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110308</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562437-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011019531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022706</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110727</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562438-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011036111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>4 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562439-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015529</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022276</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>20 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562440-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011004191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022276</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562441-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562442-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011019068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024029</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562443-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011056589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562444-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011043538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>253</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023252</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562445-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011005908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1017676</drugbatchnumb>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562446-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACLONEX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562447-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011065866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027446</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111130</drugenddate>
        <drugtreatmentduration>69</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562448-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011007637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562449-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012012385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562450-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012017143</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562451-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011010059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022707</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562452-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562453-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011011884</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>125.17</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022705</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562454-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011005938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93.44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +VIT D</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>125 MUG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>0.8 ML, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIROXICAM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021467</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110204</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562455-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043838</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562456-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562457-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562458-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>146</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562459-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011008751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562460-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562461-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011021845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INGROWN HAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562462-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011011608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.365</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562463-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562464-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562465-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562466-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562467-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562468-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562469-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562470-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562471-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562472-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562473-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562474-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041303</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562475-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028484</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562476-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562477-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029707</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562478-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562479-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562480-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562481-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562482-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562483-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-USASP2012042436</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK, 2X/WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562484-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043909</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562485-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562486-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562487-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043989</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562488-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011063907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>30</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562489-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562490-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011020603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020940</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562491-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029464</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562492-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562493-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042792</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562494-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>267</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562495-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562496-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011061545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBEX                             /00012002/</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027446</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562497-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011048750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DRYNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025531</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562498-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562499-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562500-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562501-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562502-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562503-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562504-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562505-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562506-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562507-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACARODERMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031275</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562508-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041636</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562509-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041941</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029314</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562510-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562511-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041857</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562512-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562513-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562514-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562515-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562516-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029185</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562517-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562518-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040514</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562519-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562520-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562521-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030737</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562522-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990821</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562523-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562524-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562525-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041673</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562526-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562527-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562528-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041931</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562529-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562530-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011996</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>C872291</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>C871830,872291</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562531-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562532-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562533-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562534-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562535-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562536-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562537-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562538-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030320</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562539-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562540-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>399</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562541-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562542-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>205</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562543-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562544-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562545-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562546-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028485</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562547-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562548-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562549-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562550-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562551-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562552-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562553-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042105</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562554-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562555-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PARATHYROID HORMONE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562556-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562557-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562558-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562559-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562560-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562561-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562562-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GILEAD-2012-0058858</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIREAD</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562563-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>100</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029718</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562564-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562565-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562566-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562567-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562568-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562569-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562570-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031288</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562571-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562572-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030768</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562573-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562574-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562575-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562576-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562577-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042583</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562578-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029185</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562579-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562580-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562581-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562582-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562583-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562584-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042798</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562585-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101215</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200939451NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562586-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562587-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090331</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562588-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562589-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029703</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562590-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043074</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562591-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562592-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562593-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562594-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562595-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562596-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562597-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562598-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562599-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562600-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562601-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562602-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562603-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562604-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562605-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011560</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562606-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1205USA04390</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NORMOCHROMIC NORMOCYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM PRIMARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20001001</drugenddate>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100405</drugenddate>
        <drugtreatmentduration>280</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100604</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562607-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562608-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042649</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030761</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562609-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042685</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562610-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042708</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>4139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562611-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562612-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562613-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030092</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562614-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562615-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562616-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562617-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562618-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562619-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042643</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562620-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562621-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042725</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031848</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>SJOGREN'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562622-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562623-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562624-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562625-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>1272</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562626-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562627-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562628-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562629-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562630-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562631-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562632-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562633-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562634-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043653</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562635-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562636-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043698</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562637-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562638-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>1560</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562639-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028484</drugbatchnumb>
        <drugdosagetext>12.5 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562640-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562641-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562642-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043988</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>SPONDYLOARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562643-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043901</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040304</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562644-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110519</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562645-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562646-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028229</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562647-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTIOUS MONONUCLEOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562648-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562649-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027564</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562650-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043895</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562651-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF NEEDLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562652-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562653-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562654-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562655-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043998</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562656-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044091</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562657-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562658-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562659-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044067</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562660-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043921</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562661-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562662-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>2377</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562663-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562664-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043870</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562665-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562666-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562667-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562668-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562669-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022705</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562670-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044103</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562671-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562672-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044071</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030759</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562673-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562674-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562675-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562676-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562677-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-11P-056-0849901-01</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DETACHMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100311</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562678-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960330-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL TURBINATE ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugindication>ORAL HERPES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILLS</medicinalproduct>
        <drugdosagetext>ONE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREVA ONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562679-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0962800-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TORSADE DE POINTES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugindication>INDUCTION OF ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROUS OXIDE</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020478</drugauthorizationnumb>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VENTRICULAR EXTRASYSTOLES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOFLURANE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.0-1.5%</drugdosagetext>
        <drugindication>ANAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562680-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-WATSON-2012-13312</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>3 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PSYCHOTIC BEHAVIOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076928</drugauthorizationnumb>
        <drugdosagetext>25 MG, Q 2 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562681-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ARROW-2012-12993</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>100 UNITS DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>075961</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562682-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-WATSON-2012-13112</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KERATOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OPACITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076179</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>1372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562683-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ARROW-2012-13343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENZYME INHIBITION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075662</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>10 MG, QHS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562684-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-WATSON-2012-12989</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KOUNIS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070435</drugauthorizationnumb>
        <drugdosagetext>400 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562685-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-13253</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>20 MG, DAILY, IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL D3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA                              /00142201/</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>15 MG, DAILY AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070049</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562686-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-13031</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 ?G, TID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>065145</drugauthorizationnumb>
        <drugdosagetext>250 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562687-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-13241</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075485</drugauthorizationnumb>
        <drugdosagetext>600/300/600</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>70 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY, NOCTE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075485</drugauthorizationnumb>
        <drugdosagetext>UNK, 300 UNK, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562688-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-13033</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>1 DF, TID TAKE FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAHISTINE DIHYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>16 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>070035</drugauthorizationnumb>
        <drugdosagetext>UNK, TAKE FOR 5 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562689-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-WATSON-2012-13113</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL DEPOSITS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076179</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>793</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562690-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-WATSON-2012-13137</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>075347</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080711</drugenddate>
        <drugtreatmentduration>116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>200 MG, UNK, 4 SEPERATE DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090206</drugenddate>
        <drugtreatmentduration>717</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugdosagetext>3 MG, BID, GIVEN 20</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562691-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-WATSON-2012-12978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>090081</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110907</drugenddate>
        <drugtreatmentduration>143</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562692-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-WATSON-2012-13088</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR TOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPOSIT EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugbatchnumb>UNCONFIRMED</drugbatchnumb>
        <drugauthorizationnumb>076179</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugtreatmentduration>1342</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562693-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FACIAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562694-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562695-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043344</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562696-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562697-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562698-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028484</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562699-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562700-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562701-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562702-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043642</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562703-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562704-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562705-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028209</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562706-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562707-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562708-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029464</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562709-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562710-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562711-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562712-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562713-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044075</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562714-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043994</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562715-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562716-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562717-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044082</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562718-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL442227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029464</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018888</drugbatchnumb>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562719-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030759</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562720-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562721-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044212</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562722-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562723-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562724-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562725-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562726-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562727-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562728-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044281</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562729-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562730-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMLA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.8ML FROM THE 25 MG VIAL ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562731-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562732-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562733-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562734-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562735-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562736-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044123</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562737-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562738-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562739-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044106</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562740-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562741-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044270</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562742-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030089</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562743-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562744-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562745-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044072</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562746-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044060</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATED MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562747-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562748-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043928</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562749-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562750-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028224</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562751-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044240</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562752-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044305</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562753-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562754-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029185</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562755-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043903</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562756-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562757-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562758-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044231</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562759-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562760-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562761-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, ONCE IN TEN DAY</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562762-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562763-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012002006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOSIDEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027240</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>10 MEQ, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugdosagetext>25 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028229</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562764-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562765-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044388</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562766-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031336</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562767-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562768-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030084</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562769-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1018885</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562770-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>4927</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562771-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562772-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562773-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562774-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562775-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044567</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562776-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562777-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562778-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044283</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562779-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031288</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562780-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028485</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562781-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562782-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044628</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562783-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562784-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023550</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562785-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011066012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027241</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562786-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011009492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1020938</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562787-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044686</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562788-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562789-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562790-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562791-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044736</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562792-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562793-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011012510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL BED BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMADESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PIGMENTATION DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021465</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110331</drugenddate>
        <drugtreatmentduration>2184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACLONEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562794-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562795-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044704</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COSTOCHONDRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562796-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044718</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562797-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030759</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>231</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562798-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044701</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RECALL REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562799-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAMMA-GLUTAMYLTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562800-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044707</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562801-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011063748</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024027</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMISIL                            /00992601/</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562802-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562803-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562804-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044700</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562805-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562806-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011017513</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022706</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562807-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562808-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044461</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCOLEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562809-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562810-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031336</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562811-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562812-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDICITIS PERFORATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562813-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562814-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012006958</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028209</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562815-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031286</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562816-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044249</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562817-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011064214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026663</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027239</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562818-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562819-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011013950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022706</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562820-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>B-CELL LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562821-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011015473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022706</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562822-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562823-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044699</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562824-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562825-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562826-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562827-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562828-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562829-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562830-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562831-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562832-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562833-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562834-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562835-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562836-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562837-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562838-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562839-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562840-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562841-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562842-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045370</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562843-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562844-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562845-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562846-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029128</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562847-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562848-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100330</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562849-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028485</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562850-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045391</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562851-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562852-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045380</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL DISCHARGE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030737</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562853-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562854-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562855-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>615</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562856-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030761</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562857-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044944</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562858-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044730</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562859-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562860-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562861-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044712</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562862-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562863-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045010</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562864-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562865-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027564</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562866-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562867-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044684</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562868-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562869-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562870-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562871-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562872-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044926</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562873-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044739</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562874-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011014290</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>97.052</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COCCIDIOIDOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562875-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011019382</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023551</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562876-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562877-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044929</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562878-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011026498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>1440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562879-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110828</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562880-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011019424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.785</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER                     /01292501/</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ-10</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1023548</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110610</drugenddate>
        <drugtreatmentduration>102</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2.5 MG, Q10MIN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTER C                            /00008001/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESERVISION LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562881-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045012</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562882-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562883-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045086</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562884-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562885-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT PRODUCT STORAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562886-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562887-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.866</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562888-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562889-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562890-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562891-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011064421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562892-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562893-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562894-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045037</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562895-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045094</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562896-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562897-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562898-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562899-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562900-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562901-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045092</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024948</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562902-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562903-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562904-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562905-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562906-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562907-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562908-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045090</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024026</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562909-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045140</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562910-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045050</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562911-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562912-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562913-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562914-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562915-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562916-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024365</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562917-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045356</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562918-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562919-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562920-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045443</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562921-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562922-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562923-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562924-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562925-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045362</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562926-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030760</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562927-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>0.4 ML, 2 TIMES/WK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562928-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562929-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562930-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562931-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030759</drugbatchnumb>
        <drugdosagetext>50 MG, ONCE IN 8 DAYS</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562932-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562933-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562934-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562935-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562936-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031264</drugbatchnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562937-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562938-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562939-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RECALL REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562940-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029129</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562941-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028229</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562942-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562943-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562944-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562945-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562946-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562947-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>2353</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562948-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562949-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080429</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562950-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562951-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562952-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562953-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562954-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045054</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562955-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562956-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562957-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562958-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WISDOM TEETH REMOVAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562959-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045043</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562960-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562961-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562962-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029464</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562963-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045336</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562964-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045348</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562965-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045360</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562966-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021463</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>859</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562967-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562968-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562969-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045358</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562970-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562971-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045378</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021463</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>859</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562972-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562973-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>108</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562974-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031955</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562975-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045423</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562976-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562977-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045446</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562978-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562979-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045738</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562980-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTED CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100117</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562981-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562982-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562983-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562984-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045604</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029185</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562985-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562986-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047669</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562987-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562988-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562989-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010007543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562990-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562991-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045223</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562992-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562993-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562994-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011026641</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS BULLOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024025</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111024</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROBID                           /00003201/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562995-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045456</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>POLYARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>1175</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562996-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030737</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>5308</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562997-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562998-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8562999-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045561</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563000-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012031184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.435</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563001-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045588</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563002-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011068602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS INFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>2017</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563003-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563004-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563005-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045585</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563006-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045607</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029185</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563007-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563008-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045760</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027242</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>4627</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563009-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERTUSSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563010-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563011-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563012-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045762</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563013-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563014-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563015-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563016-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045595</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563017-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563018-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563019-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031264</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563020-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045694</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563021-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045764</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563022-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563023-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563024-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012016206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563025-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563026-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563027-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563028-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026663</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563029-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563030-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045806</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563031-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563032-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563033-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563034-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERIARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563035-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563036-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045829</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563037-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563038-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563039-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045835</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031286</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563040-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1017419</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563041-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563042-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030090</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563043-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045818</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563044-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563045-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045855</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563046-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563047-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045876</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563048-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563049-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045954</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563050-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031288</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563051-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LATEX ALLERGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563052-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031955</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563053-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563054-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563055-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563056-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031289</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563057-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028720</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100715</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563058-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563059-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040468</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563060-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563061-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045612</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563062-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563063-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028486</drugbatchnumb>
        <drugdosagetext>25 MG, Q2WK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040602</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563064-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563065-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025522</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563066-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031288</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563067-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY CONTRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030089</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563068-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045860</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563069-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045852</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563070-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAIR TEXTURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563071-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563072-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563073-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030092</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563074-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563075-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045998</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563076-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563077-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563078-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563079-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563080-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563081-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563082-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>8 TABS/ WEEKLY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563083-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044547</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563084-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120505</drugenddate>
        <drugtreatmentduration>4388</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563085-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563086-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-15184NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563087-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563088-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046201</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563089-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046167</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563090-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563091-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563092-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046407</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563093-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563094-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563095-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563096-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563097-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563098-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563099-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563100-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>7 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563101-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563102-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030089</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563103-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563104-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE BURNS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030737</drugbatchnumb>
        <drugdosagetext>25 MG, Q4WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563105-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563106-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563107-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563108-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563109-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563110-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563111-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046258</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563112-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563113-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563114-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046277</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563115-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046341</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563116-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563117-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045982</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563118-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563119-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563120-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046183</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563121-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563122-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563123-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563124-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTED BITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563125-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045984</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029705</drugbatchnumb>
        <drugdosagetext>50 MG, EVERY FIVE DAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563126-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563127-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563128-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563129-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563130-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>370</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563131-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563132-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563133-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563134-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021304</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563135-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046142</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563136-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563137-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012010858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024024</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563138-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011014081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024029</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563139-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563140-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563141-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563142-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046020</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563143-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563144-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563145-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012035107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563146-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012036925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563147-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563148-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.737</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>2500 MUG, QD</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG/ML, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR UNSPEC</medicinalproduct>
        <drugdosagetext>250 MUG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>1% CREAM EXTERNAL, APPLY AFF AREA BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, 1 TABLETS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL HFA                      /00139501/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>0.05% CREAM EXTERNAL, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q 10</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563149-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563150-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
        <drugtreatmentduration>2876</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563151-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563152-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012036490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563153-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALINDROMIC RHEUMATISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>3453</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563154-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046042</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563155-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012032794</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.179</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG/0.98ML, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563156-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044392</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563157-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563158-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044393</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563159-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011004554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALOCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021301</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101231</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563160-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563161-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MACULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563162-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044399</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563163-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563164-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046411</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563165-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563166-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563167-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563168-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563169-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031286</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563170-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046530</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>1620</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563171-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011004186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>96.599</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1021468</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110214</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563172-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COCCYDYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563173-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563174-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563175-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041217</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028224</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563176-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563177-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563178-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563179-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563180-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563181-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030092</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563182-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563183-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563184-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563185-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563186-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046529</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563187-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563188-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563189-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563190-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563191-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563192-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046535</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031288</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563193-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563194-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 3 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563195-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046625</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE COLOUR CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROXINE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>132</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563196-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563197-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012029014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
        <drugtreatmentduration>3745</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563198-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563199-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012040834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563200-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563201-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030086</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563202-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563203-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046545</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WALKING AID USER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031289</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563204-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>17.5 G, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>7 G, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563205-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563206-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043690</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563207-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012024559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022705</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563208-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563209-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046830</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563210-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT PRODUCT STORAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563211-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563212-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016444</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67.574</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022705</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563213-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101221</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941596NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>122.73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>122</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>60 MG (DAILY DOSE), QD,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), QD,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563214-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-GILEAD-2012-0058115</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPINAVIR/RITONAVIR</medicinalproduct>
        <drugdosagetext>4 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563215-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563216-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012043205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028485</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563217-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046796</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029315</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563218-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046800</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563219-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563220-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHTHOUS STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563221-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011028374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1024027</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563222-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012029455</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID MARGIN CRUSTING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563223-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563224-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563225-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563226-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563227-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563228-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028224</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563229-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563230-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563231-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PUSTULAR PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563232-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012035657</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563233-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563234-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012045842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563235-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011003654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCARLET FEVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563236-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011040083</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1025530</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563237-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027445</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563238-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011055275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563239-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563240-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030089</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563241-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041066</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>20 TO 12.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563242-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563243-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563244-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563245-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011016445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563246-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563247-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046668</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563248-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563249-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>UNK 8 TABLETS WEEKLY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563250-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563251-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563252-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563253-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563254-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046890</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563255-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012039209</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030086</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>765</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563256-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011061124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE WITH AURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563257-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563258-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563259-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563260-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563261-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563262-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563263-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563264-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046597</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNE SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563265-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RECALL REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563266-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563267-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG EVERY 2 WEEKS TO 1 A MONTH</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563268-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046627</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563269-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012038026</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563270-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563271-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563272-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563273-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047046</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563274-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563275-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047164</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563276-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563277-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563278-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563279-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047065</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563280-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563281-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563282-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563283-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563284-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047097</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563285-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1022707</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563286-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>3 TABS/QWK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029705</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563287-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031288</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563288-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563289-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012035422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.864</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>2800</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563290-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563291-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029708</drugbatchnumb>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563292-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031286</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563293-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047187</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563294-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563295-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563296-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011063961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, Q3WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563297-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563298-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012028794</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1026343</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563299-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042938</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563300-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKYLOSING SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563301-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563302-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047203</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563303-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047220</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563304-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563305-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563306-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563307-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563308-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563309-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047251</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563310-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012034837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, 2 TIMES/WK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030097</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563311-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047240</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563312-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030759</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563313-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047381</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563314-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047339</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563315-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563316-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029464</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563317-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047385</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563318-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030761</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563319-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>44 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563320-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030094</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563321-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563322-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAND FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031265</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563323-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563324-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563325-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047373</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563326-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563327-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563328-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047333</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DESTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029705</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563329-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047452</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563330-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563331-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030096</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563332-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563333-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012042317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.365</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563334-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563335-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047357</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563336-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563337-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047442</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563338-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, QWK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563339-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012041243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82.086</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RECALL REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031290</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563340-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563341-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563342-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011005509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIATIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1017577</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1017577</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563343-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012037672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563344-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047447</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563345-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563346-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563347-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047531</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029706</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563348-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563349-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563350-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563351-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563352-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047749</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563353-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563354-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047596</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563355-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012044049</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030093</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563356-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563357-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563358-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>2741</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563359-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563360-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563361-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563362-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047536</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563363-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS PYROPHOSPHATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563364-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047822</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563365-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563366-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047492</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563367-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031264</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563368-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563369-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047751</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563370-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>2116</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563371-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048045</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563372-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563373-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563374-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030765</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563375-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563376-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563377-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0919662-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugdosagetext>10/650 MG</drugdosagetext>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugindication>OSTEONECROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563378-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874162-01</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563379-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909408-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>250/50MCG</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>70/30</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOVONEX</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563380-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>3240</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563381-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031214</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563382-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047511</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563383-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563384-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES VIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563385-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047550</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE ALLERGIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563386-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563387-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029185</drugbatchnumb>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563388-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563389-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563390-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047500</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031287</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563391-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047578</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563392-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563393-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1027445</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563394-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047697</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563395-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030085</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563396-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563397-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047750</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563398-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563399-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-KDL232956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031215</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563400-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030086</drugbatchnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563401-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030761</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563402-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563403-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047864</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563404-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563405-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563406-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563407-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563408-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563409-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DIASTOLIC DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563410-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563411-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>2110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563412-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563413-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563414-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563415-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047863</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563416-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563417-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047831</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563418-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047882</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031954</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563419-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563420-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047896</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563421-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031212</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563422-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563423-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047872</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031274</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563424-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563425-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047828</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563426-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, Q2WK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563427-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563428-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047900</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031272</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563429-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563430-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563431-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031273</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563432-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1028224</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563433-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101008</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942456NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
        <drugdosagetext>3 TABLETS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVIANE-28</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>USE AS NEEDED WITH HER PERIODS</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYMYXIN B SULFATE W/TRIMETHOPRIM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCLE RELAXANT</medicinalproduct>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATUSS DR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>DYSFUNCTIONAL UTERINE BLEEDING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL + ETHINYL ESTRADIOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563434-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2012018326</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAG 2                              /00454301/</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>30 MUG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120208</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563435-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100908</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200943902NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47.727</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800 MG (DAILY DOSE), PRN, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
        <drugdosagetext>APAP Q4H, PRN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090915</drugenddate>
        <drugtreatmentduration>243</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091115</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>HYDROCODONE/APAP Q4H, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563436-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111105</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942458NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>143.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VAGINAL HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070918</drugenddate>
        <drugtreatmentduration>222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563437-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120103</drugenddate>
        <drugtreatmentduration>1435</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563438-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101229</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563439-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0958563-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>102042E</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563440-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ABBOTT-12P-035-0917050-00</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL ABOVE THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020593</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE: 1.6 GM</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563441-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-GILEAD-2012-0058942</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugauthorizationnumb>021937</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563442-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563443-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101229</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201010676NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER CHOLESTEROLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROZINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563444-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>073288</drugauthorizationnumb>
        <drugdosagetext>50 MG,</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563445-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014219</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugdosagetext>0.062 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>073288</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563446-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB064943</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugauthorizationnumb>073288</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563447-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2011US05095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110318</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugauthorizationnumb>090250</drugauthorizationnumb>
        <drugdosagetext>1 G, Q12H</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugdosagetext>142 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110303</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMPARATOR TRASTUZUMAB</medicinalproduct>
        <drugdosagetext>137 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110310</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>SWOLLEN TONGUE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563448-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0961681-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>018081</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563449-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011319</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563450-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMATOUS LIVER DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563451-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563452-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563453-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZASITE</medicinalproduct>
        <drugauthorizationnumb>050810</drugauthorizationnumb>
        <drugdosagetext>1 DROP</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CONJUNCTIVITIS INFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563454-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563455-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101102</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201011808NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>140.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040701</drugenddate>
        <drugtreatmentduration>882</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALEVE COLD AND SINUS</medicinalproduct>
        <drugdosagetext>2002 AND 2006</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040321</drugenddate>
        <drugtreatmentduration>673</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071125</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563456-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110324</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201011737NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>82350A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>PHARMACY RECORDS: 3 YAZ REFILLS WERE NOTED ON 05MAY2009, 09JUL2009 AND 17AUG2009.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090817</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREIMET</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
        <drugindication>DYSURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>83702A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090817</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>82356A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090817</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>84563A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090817</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090415</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563457-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012GB022901</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101110</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugdosagetext>160 MG, QMO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTI-INFECTIVE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>64 MG/H, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101017</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>64 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugdosagetext>160 MG, QMO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101018</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101109</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>POLYURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101111</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563458-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-GILEAD-2012-0058937</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>2094</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563459-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961536-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUPRON DEPOT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020517</drugauthorizationnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563460-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0962087-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563461-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350265ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>95.255</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugauthorizationnumb>078773</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORACTEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563462-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2012SA053587</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugdosagetext>MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESOMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563463-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALLERGAN-1210350US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugdosagetext>UNK, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOTULINUM TOXIN TYPE A</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563464-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR012607</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugauthorizationnumb>18086</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563465-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1067227</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563466-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-1093422</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 15/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 16/JUN/2012</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 15/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 15/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 19/JUN/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TRANSIENT ISCHAEMIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 15/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563467-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1087016</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOSOMAL ADRIAMYCIN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IFOSFAMIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINDESINE</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRARUBICIN</medicinalproduct>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563468-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-ROCHE-1067658</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROPATHY TOXIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLATE DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEVIRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563469-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1054295</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B00230,B10130</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B00230,B10130</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B00230,B10130</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563470-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1052845</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110302</drugenddate>
        <drugtreatmentduration>743</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100106</drugenddate>
        <drugtreatmentduration>743</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugtreatmentduration>743</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563471-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RB-042945-12</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FREON GAS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSAGE DETAILS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020733</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSAGE DETAILS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUBOXONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20733</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSAGE DETAILS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563472-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563473-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>24 IU, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>30 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>2.5 (4 IN D) MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>80 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugdosagetext>0.4 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>90 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>8 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>30 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>750 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563474-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0049200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>021356</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563475-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-TEVA-351493ISR</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED</medicinalproduct>
        <drugindication>MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOL CAPSULE MGA 40MG</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM;</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIUMZUUR TABLET 0,5MG</medicinalproduct>
        <drugdosagetext>.5 MILLIGRAM;</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMINE INJVLST 500UG/ML</medicinalproduct>
        <drugdosagetext>TIMES PER 2 ML</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>74656</drugauthorizationnumb>
        <drugindication>MESOTHELIOMA MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563476-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QRS COMPLEX PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>2500 MG, ONCE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>90 MG, ONCE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563477-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563478-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350291ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077048</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>077048</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563479-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugauthorizationnumb>021067</drugauthorizationnumb>
        <drugdosagetext>220 MICROGRAM, BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugtreatmentduration>915</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563480-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA053620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>85.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACEMAKER GENERATED ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563481-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350427ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BALNEUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEVYN AG GENTLE BORDER</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugauthorizationnumb>076410</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563482-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA053630</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMODULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563483-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563484-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563485-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563486-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-TEVA-350525ISR</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBAMAZEPINE</medicinalproduct>
        <drugauthorizationnumb>070541</drugauthorizationnumb>
        <drugdosagetext>150 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563487-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000427</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563488-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563489-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL DRUGS AFFECTING FOETUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugdosagetext>MATERNAL DOSE</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563490-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA010702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>16+2.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOLAMIN FLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOTU KOLA</medicinalproduct>
        <drugdosagetext>UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>16+5MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSALDINA (CAFFEINE (+) DIPYRONE (+) ISOMETHEPTENE HYDROCHLORIDE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563491-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350269ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TABPHYN MR</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYPROTERONE ACETATE</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>40145</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563492-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugbatchnumb>10114639</drugbatchnumb>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563493-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015649</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER UNKNOWN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563494-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120403</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563495-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015613</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563496-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER CHEWABLE TABLET</medicinalproduct>
        <drugdosagetext>1-3 DF, PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563497-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US010541</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER ORANGE POWDER</medicinalproduct>
        <drugbatchnumb>24179001</drugbatchnumb>
        <drugdosagetext>2 TSP, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563498-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120525</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US009963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADHESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNCTIONAL GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMACH MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX MAX ANTACID+ANTIGAS</medicinalproduct>
        <drugbatchnumb>10108289</drugbatchnumb>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS MAX LIQ UNKNOWN</medicinalproduct>
        <drugdosagetext>2 TSP, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563499-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US013265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER SUGAR FREE</medicinalproduct>
        <drugdosagetext>2-3 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIVERTICULITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563500-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US009352</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYMPANIC MEMBRANE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL BED BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE EAR EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG THERAPY NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER W/ WHEAT DEXTRIN</medicinalproduct>
        <drugdosagetext>3 TSP, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BOWEL MOVEMENT IRREGULARITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER STICK PACKS</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>UNK, QAM</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFLAVONOID</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER W/ WHEAT DEXTRIN</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563501-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563502-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1204USA00893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOETIN</medicinalproduct>
        <drugdosagetext>1 VIAL EVEY 15 DAYS</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>215</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugdosagetext>INCREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120208</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAG 2</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugdosagetext>ONE SACHET</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>30 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>1 PATCH</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0805</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>4 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>21337</drugauthorizationnumb>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>ONE VIAL EVERY 15 DAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563503-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA03268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RED YEAST</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STATIN (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563504-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA00558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN STEM STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOCORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTINE</medicinalproduct>
        <drugdosagetext>75 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBIDECARENONE</medicinalproduct>
        <drugdosagetext>10 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 ?G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
        <drugdosagetext>UNK UNK, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1MG HALF TABLET</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG,ONE AND HALF TABLET, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>5 MG, 4 TABLETS,DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>4 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>320MG-25MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>50 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>0.5 MG 4 TABLETS DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>UNK UNK, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugdosagetext>0.03 %, BID</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>1 CAPSULE, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563505-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0963133-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEKRISTOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563506-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0961014-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARATHYROIDECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugdosagetext>10 MCG PER WEEK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERPARATHYROIDISM SECONDARY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563507-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0961025-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020819</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563508-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP020758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugdosagetext>200/5 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563509-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011469</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[COMPOSITION UNSPECIFIED]</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563510-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960516-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDURAL INJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>140702E</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563511-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>70 IU, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>88 MICROGRAM, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVOPROST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>50000 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugdosagetext>30 G, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>200 MG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563512-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET XR</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563513-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-UCBSA-062756</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR</medicinalproduct>
        <drugdosagetext>100 MG/25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugauthorizationnumb>022064</drugauthorizationnumb>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG: 0.5 DF 2 TIMES A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563514-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-059432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.23</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA XR</medicinalproduct>
        <drugbatchnumb>60811</drugbatchnumb>
        <drugauthorizationnumb>022285</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563515-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>750 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563516-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563517-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-UCBSA-062764</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021872</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563518-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-AMGEN-AUTSP2012034574</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL-D-VITA</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIRMAGON                           /01764801/</medicinalproduct>
        <drugdosagetext>80 MG, Q4WK</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugindication>PROSTATE CANCER METASTATIC</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563519-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011408</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563520-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1208USA001029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TICAGRELOR</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563521-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-061124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE (WEANED OFF)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACOSAMIDE</medicinalproduct>
        <drugauthorizationnumb>022253</drugauthorizationnumb>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN</medicinalproduct>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563522-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2012038638</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563523-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2012046962</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563524-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563525-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-UCBSA-062668</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIMPAT</medicinalproduct>
        <drugauthorizationnumb>022253</drugauthorizationnumb>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563526-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2012047628</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>UNK UNK, Q6MO</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563527-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2012047910</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111219</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>171 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111219</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>100 MG/M2, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>600 MG/M2, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563528-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-AMGEN-BELSP2012034113</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTRAPID                           /00646001/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEOVIT D3</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NESTROLAN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDENOFALK</medicinalproduct>
        <drugdosagetext>3 MG, QD</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOGLYCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORUNO</medicinalproduct>
        <drugdosagetext>16 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563529-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936314-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120330</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563530-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563531-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B2                         /00154901/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELESTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563532-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012023440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugbatchnumb>1021961</drugbatchnumb>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563533-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-AMGEN-SVNSP2012047984</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOLPAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563534-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2012044178</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563535-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16792780</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>LUNG CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563536-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-BRISTOL-MYERS SQUIBB COMPANY-16792152</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN AQ</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugdosagetext>ALSO RECEIVED ON 22 FEB</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MALIGNANT PERITONEAL NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563537-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120802</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-BRISTOL-MYERS SQUIBB COMPANY-16795320</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugauthorizationnumb>016295</drugauthorizationnumb>
        <drugindication>THROMBOCYTOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563538-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRSP2012046761</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563539-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-AMGEN-SWECT2012046719</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>10 MG/ML, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111127</drugenddate>
        <drugtreatmentduration>390</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTINATE COMBI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563540-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012047281</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563541-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2012046963</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NECROTISING COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNOSUPPRESSANTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugindication>TESTICULAR CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563542-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16353914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPLENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BARACLUDE</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563543-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14299432</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM : 10MG/KG,475MG, ALSO TOOK 8850 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563544-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16802951</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>DUE ON 13JUL12</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563545-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16686BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201920A,261881</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563546-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-AMGEN-NZLSP2012038568</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugbatchnumb>1031190</drugbatchnumb>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>1439</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563547-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZASITE</medicinalproduct>
        <drugauthorizationnumb>050810</drugauthorizationnumb>
        <drugindication>EYE INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563548-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2012046071</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSOAS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR COMPLICATION ASSOCIATED WITH DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100509</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100509</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25.0 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100602</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563549-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-AMGEN-GRCSP2012044216</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ENDOTHELIITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>T4</medicinalproduct>
        <drugdosagetext>112 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563550-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010777</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563551-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2012038636</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>400 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>50 DF, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRIDAMOL</medicinalproduct>
        <drugdosagetext>200 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVISCON</medicinalproduct>
        <drugdosagetext>100 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1000 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563552-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-AMGEN-AUSSP2012027037</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT STORAGE OF DRUG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20MG, EVERY 2ND DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>10 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563553-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563554-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>69 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UP TO FOUR TIMES A DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1 TO 6 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563555-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUCT2012042903</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYRINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H                         /00016201/</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>125</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H                         /00016201/</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H                         /00016201/</medicinalproduct>
        <drugdosagetext>7.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOITRE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugdosagetext>1000 IU, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECORTIN-H                         /00016201/</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563556-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURED SACRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANIMAL SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER STAGE IV</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563557-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1204USA03609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>6 IN ONE DAY, 6 DF QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563558-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNSP2012040386</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563559-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-AMGEN-GBRCT2012044491</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTHIADEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>25 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563560-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-056823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EP3</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563561-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563562-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047971</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563563-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-067693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EHH</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563564-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16690BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201055A</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION NOT FURTHER SPECIFIED</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563565-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2012047270</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TIBIA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563566-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-AMGEN-COLSP2012034249</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>16 MG ONCE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG, TWICE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, ONCE A DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugdosagetext>8 MG ONCE A DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563567-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2012047328</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563568-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2012047007</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MELKERSSON-ROSENTHAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS GRANULOMATOSA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, 2X/WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563569-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
        <drugdosagetext>50/500MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563570-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-TURSP2012025179</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120317</drugenddate>
        <drugtreatmentduration>511</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563571-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-AMGEN-NLDSP2012047279</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/WEEK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563572-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-TURSP2012024869</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563573-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012046937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugbatchnumb>1009239</drugbatchnumb>
        <drugdosagetext>60 MUG, UNK</drugdosagetext>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563574-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-066675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00F5Z</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563575-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CY-AMGEN-CYPSP2012045141</companynumb>
    <primarysource>
      <reportercountry>CYPRUS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563576-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugdosagetext>200 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563577-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE IMMEASURABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563578-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-068939</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00DKW</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 ?G/D, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563579-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-053376</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00B9</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563580-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA05437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563581-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>1CO7004</drugbatchnumb>
        <drugdosagetext>150 MICROGRAM, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563582-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16645BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563583-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16643BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563584-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012036038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031657</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG, QWK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563585-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugauthorizationnumb>020387</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563586-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugauthorizationnumb>020864</drugauthorizationnumb>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMEDIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARATRIPTAN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563587-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000542</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563588-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-009507513-2012SP024879</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMOZOLOMIDE</medicinalproduct>
        <drugauthorizationnumb>022277</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UPDATE (21MAY2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>0.5 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTROCYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UPDATE (21MAY2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>UPDATE (21MAY2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563589-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA00425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>37</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563590-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA02615</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VORINOSTAT-MYCOSIS FUNGOIDES</medicinalproduct>
        <drugauthorizationnumb>21991</drugauthorizationnumb>
        <drugdosagetext>300 MG, ON DAYS 1- 5,WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAR</medicinalproduct>
        <drugdosagetext>75 MG/M2, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA MULTIFORME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563591-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP023453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563592-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>2C05000</drugbatchnumb>
        <drugdosagetext>80 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563593-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1208FRA000335</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugauthorizationnumb>022145</drugauthorizationnumb>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563594-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP025157</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563595-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000570</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563596-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563597-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR012578</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>1.25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>15 ML, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>300 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAPAIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFUMORPH</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563598-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009733</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugdosagetext>1 UNK, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>1 DF, BIW</drugdosagetext>
        <drugindication>ESSENTIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>1 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULINASTATIN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>1 UNK, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563599-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1208JPN000036</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD MAGNESIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TETANY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>10 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>12 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563600-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16648BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563601-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2008BI012632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080505</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563602-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI016111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32101</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563603-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI019587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19971220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563604-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI006295</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAESTHETIC COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANESTHESIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563605-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI015227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990805</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563606-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FUSION SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061107</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FATTY ACIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563607-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI022906</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001030</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563608-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CANCER STAGE IV</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563609-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563610-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563611-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32167</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563612-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI031842</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563613-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI046168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563614-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BIOGENIDEC-2011BI048333</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110822</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563615-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BIOGENIDEC-2012BI000704</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBOTIC</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIPHASIL-21</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563616-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI006814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563617-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-BIOGENIDEC-2012BI011545</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563618-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI012841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563619-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2012BI016755</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>IRON DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563620-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI017308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111214</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563621-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563622-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI020110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563623-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI020209</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE PSYCHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MICTURITION URGENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TREMOR</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLLAKIURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563624-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI020963</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563625-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BIOGENIDEC-2012BI021368</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563626-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563627-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021705</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563628-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563629-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI022614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563630-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BIOGENIDEC-2012BI022649</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZEPAM</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRITION</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563631-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-BIOGENIDEC-2012BI024845</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563632-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BIOGENIDEC-2012BI025031</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563633-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BIOGENIDEC-2012BI026546</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563634-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MUSCLE SPASTICITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563635-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563636-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563637-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563638-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563639-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563640-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563641-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563642-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2011BI047365</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON OPERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563643-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI005756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563644-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI010147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY COMMON VARIABLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563645-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI012841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563646-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI015644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONOPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563647-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI015841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563648-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563649-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI018590</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNE RECONSTITUTION SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563650-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI024177</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugindication>GAIT DISTURBANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563651-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI025147</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563652-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563653-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI026949</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563654-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563655-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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        <reactionmeddrapt>POOR VENOUS ACCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugindication>MULTIPLE SCLEROSIS</drugindication>
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      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070910</drugstartdate>
      </drug>
    </patient>
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    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
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    <serious>2</serious>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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    </patient>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027413</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>8563660-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
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        <drugenddate>20120521</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961121</drugstartdate>
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    </patient>
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    <safetyreportid>8563661-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
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    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
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    </patient>
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  <safetyreport>
    <safetyreportid>8563662-3</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027444</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563663-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027473</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091208</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563664-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027488</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563665-9</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20091008</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563666-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110818</drugenddate>
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    </patient>
  </safetyreport>
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    <safetyreportid>8563667-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>DYSURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070708</drugstartdate>
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    </patient>
  </safetyreport>
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    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
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    </patient>
  </safetyreport>
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    <safetyreportid>8563669-6</safetyreportid>
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    <receivedateformat>102</receivedateformat>
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    <companynumb>US-BIOGENIDEC-2012BI027753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientonsetageunit>801</patientonsetageunit>
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      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
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    </patient>
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    <safetyreportid>8563670-2</safetyreportid>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
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      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
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    </patient>
  </safetyreport>
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    <safetyreportid>8563671-4</safetyreportid>
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    <companynumb>US-BIOGENIDEC-2012BI027810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563672-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027819</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563673-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563674-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027853</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563675-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110427</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563676-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027881</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120323</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563677-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027885</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTRALISING ANTIBODIES POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563678-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563679-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027893</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563680-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563681-7</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027930</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563682-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027947</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010926</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563683-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563684-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563685-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111028</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563686-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110505</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563687-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028000</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563688-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563689-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028027</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563690-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028051</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563691-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563692-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563693-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028093</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONTROL OF LEGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563694-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111111</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563695-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028101</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563696-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028133</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563697-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563698-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COORDINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563699-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563700-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563701-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090911</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563702-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563703-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI002350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>INJECTION SITE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>P32165</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563704-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI010353</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091016</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563705-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI025111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020313</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563706-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2010BI027723</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563707-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI002975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563708-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI011274</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563709-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI021711</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563710-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI024677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R32015</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563711-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI024997</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>READING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563712-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE WARMTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563713-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563714-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563715-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027367</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20021011</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563716-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563717-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563718-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027672</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563719-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563720-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563721-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563722-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027935</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563723-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563724-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI027967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563725-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028021</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563726-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028079</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563727-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563728-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINE (NOS)</medicinalproduct>
        <drugindication>CARDIAC VALVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICINE (NOS)</medicinalproduct>
        <drugindication>HYPOTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563729-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028195</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563730-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028209</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563731-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020322</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563732-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020415</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563733-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028228</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563734-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028230</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563735-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563736-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563737-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028245</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563738-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563739-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028254</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563740-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021011</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugbatchnumb>R32015</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563741-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028256</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERMETABOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563742-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19991015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563743-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563744-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563745-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563746-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BIOGENIDEC-2012BI028460</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVONEX</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563747-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>2009BI027968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYSABRI</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563748-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1208GBR000405</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>17555</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563749-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugauthorizationnumb>020829</drugauthorizationnumb>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563750-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA011405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>21445</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugdosagetext>250 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111024</drugenddate>
        <drugtreatmentduration>144</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUZONE (INFLUENZA VIRUS SPLIT VIRION 3V VACCINE INACTIVATED)</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563751-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT CONTAINER ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugauthorizationnumb>019625</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563752-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CY-AMGEN-CYPSP2012047280</companynumb>
    <primarysource>
      <reportercountry>CYPRUS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EXOPHTHALMOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563753-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUCT2012041573</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>173</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNOSUPPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>2 X 2 HUBS</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563754-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-TURSP2012004732</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
        <drugtreatmentduration>394</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563755-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2012043160</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563756-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200935621NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
        <drugtreatmentduration>1281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081023</drugenddate>
        <drugtreatmentduration>1281</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
        <drugdosagetext>10 MG (DAILY DOSE), ,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORETIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG (DAILY DOSE), QD,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG (DAILY DOSE), QD,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORETIC</medicinalproduct>
        <drugdosagetext>50 MG (DAILY DOSE), ,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563757-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200936416NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
        <drugtreatmentduration>183</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071001</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070901</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563758-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-342558</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN                             /00036501/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110329</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOMIX 30</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>21172</drugauthorizationnumb>
        <drugdosagetext>24 IU, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETIC                           /00022001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110329</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAXAGLIPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINNAT                             /00454602/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110420</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563759-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004429</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563760-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MSD-2012SP029261</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120226</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAIVOBET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120226</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>90 ?G, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>3000 DF, QW</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 G, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>80 MICROGRAM, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120226</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110329</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563761-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012041035</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
        <drugtreatmentduration>263</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563762-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16824534</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIAZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDREA</medicinalproduct>
        <drugauthorizationnumb>016295</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563763-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200936505NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>101</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070927</drugenddate>
        <drugtreatmentduration>319</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>3200 MG (DAILY DOSE), QD, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071007</drugenddate>
        <drugtreatmentduration>332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563764-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16794927</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL INFARCT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMBOLIC CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCARDITIS NONINFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugindication>OVARIAN CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563765-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16735888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN FISSURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>ERBITUX WAS HOLD FOR 1 WEEK AND THEN RESUMED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARYNGEAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563766-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16802878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563767-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16812463</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF: 150 MCG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL HYPOTHYROIDISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugdosagetext>1 DF: 5MG TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMICRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>20357</drugauthorizationnumb>
        <drugdosagetext>1 DF: 1000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF:75 MG POWDER FOR ORAL SOLN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563768-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16803645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZERIT</medicinalproduct>
        <drugauthorizationnumb>020412</drugauthorizationnumb>
        <drugdosagetext>RECEIVED FOR 7 YEARS</drugdosagetext>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563769-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16714644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YERVOY</medicinalproduct>
        <drugdosagetext>NO OF INF:1,DOSE TAKEN FOR 2 DAYS AT DAY 1 AND 22.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563770-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TH-BRISTOL-MYERS SQUIBB COMPANY-16828758</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
        <drugtreatmentduration>133</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563771-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-16583940</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>NO OF COURSE-2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563772-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-16770091</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ACNEIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugbatchnumb>138863</drugbatchnumb>
        <drugdosagetext>1 DF:366 UNITS NOS,DOSE:200MG/M2 CYCLICAL.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
        <drugtreatmentduration>140</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
        <drugtreatmentduration>167</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563773-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16671463</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROPERITONEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTOMIN</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TASMOLIN</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>18MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090721</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070511</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080925</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORELCO</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080403</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090723</drugenddate>
        <drugtreatmentduration>477</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563774-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BRISTOL-MYERS SQUIBB COMPANY-16793135</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BONE MARROW OEDEMA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPINAVIR AND RITONAVIR</medicinalproduct>
        <drugdosagetext>1 DF= 300MG/100MG</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIDANOSINE</medicinalproduct>
        <drugauthorizationnumb>020154</drugauthorizationnumb>
        <drugindication>HIV INFECTION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563775-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16795387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugindication>TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563776-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-16806333</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOKINE RELEASE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>NO OF INFUSION:01 DRUG RESTARTED</drugdosagetext>
        <drugindication>MALIGNANT MELANOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563777-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047533</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS MICROSCOPIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER NON-FUNCTIONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS EXCISION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031336</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563778-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941202NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSVERSE SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR SAGITTAL SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JUGULAR VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMFED</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060515</drugenddate>
        <drugtreatmentduration>608</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>121</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563779-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200939107NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
        <drugtreatmentduration>2191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECEDRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>1461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563780-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047810</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHARITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1029464</drugbatchnumb>
        <drugdosagetext>25 MG, EVERY 4-5 DAYS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563781-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MSD-1207JPN013118</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEQUESTRECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>35 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugtreatmentduration>396</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563782-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1207USA007846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>22 MICROGRAM, 3 IN 1 WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>44 MICROGRAM, 3 IN 1 WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563783-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110610</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942465NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>100 MG (DAILY DOSE), ,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugdosagetext>30 MG (DAILY DOSE), ,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>100 MG (DAILY DOSE), ,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNCODEABLE ^UNCLASSIFIABLE^</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHETAMINE SULFATE</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), ,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
        <drugtreatmentduration>1119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>200 MG (DAILY DOSE), ,</drugdosagetext>
        <drugindication>ORTHOSTATIC INTOLERANCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENDOMETRIOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061106</drugenddate>
        <drugtreatmentduration>1320</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090911</drugenddate>
        <drugtreatmentduration>1667</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG (DAILY DOSE), ,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHETAMINE SULFATE</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), ,</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070808</drugenddate>
        <drugtreatmentduration>1120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563784-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942591NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>1 DF (DAILY DOSE), QD, ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGISIL</medicinalproduct>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071115</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN 1.5/30</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugdosagetext>75 MG (DAILY DOSE), ,</drugdosagetext>
        <drugindication>DYSMENORRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070615</drugenddate>
        <drugtreatmentduration>6209</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563785-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010757</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563786-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PELVIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJACULATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROGRADE EJACULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563787-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-201047470GPV</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563788-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200942647NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELNORM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVARIAN CYST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080521</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563789-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPZICOM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563790-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000024</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563791-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DALIRESP</medicinalproduct>
        <drugdosagetext>500 MICROGRAM, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASMANEX TWISTHALER</medicinalproduct>
        <drugdosagetext>220 MICROGRAM, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563792-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030084</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>3053</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563793-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011577</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SARAFEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563794-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF LIBIDO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL DISORDER MALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563795-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-57715</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>650 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
        <drugtreatmentduration>1975</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>45 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076327</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076327</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563796-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16833329</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563797-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16368334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>INF:22 LASTINF: 12JAN12,APR2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563798-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16813438</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>21986</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563799-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16809196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563800-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-BRISTOL-MYERS SQUIBB COMPANY-16835134</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL WARFARIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563801-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-56878</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INHIBITORY DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111019</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, AS NECESSARY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065174</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111030</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>90 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111030</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>065174</drugauthorizationnumb>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563802-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563803-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1208FRA000204</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMPLANON</medicinalproduct>
        <drugauthorizationnumb>021529</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111005</drugenddate>
        <drugtreatmentduration>1096</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563804-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GE HEALTHCARE MEDICAL DIAGNOSTICS-OMPQ-PR-1207S-0782</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120330</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMNIPAQUE 140</medicinalproduct>
        <drugauthorizationnumb>018956</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563805-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16653BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563809-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ENURESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAPHRIS</medicinalproduct>
        <drugauthorizationnumb>022117</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563810-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-009507513-1207NLD007720</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>1610</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563811-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-AMGEN-AUTSP2012047570</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>130 MG, Q3MO</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>75 MG, Q3WK</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugdosagetext>120 MG, Q4WK</drugdosagetext>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563821-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-VERTEX PHARMACEUTICALS INC.-000000000000001226</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563822-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-VERTEX PHARMACEUTICALS INC.-000000000000001298</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugauthorizationnumb>71832</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563823-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MA-ACCORD-014235</companynumb>
    <primarysource>
      <reportercountry>MOROCCO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>065416</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>TARGET LEVEL 8-10 NG/ML</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DOSE INCREASED TO 20MG/DAY</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BASILIXIMAB</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563824-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1031261</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563825-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANKLE OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROSTIMULATOR IMPLANTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030092</drugbatchnumb>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>812</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXALL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563828-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ACCORD-014239</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugauthorizationnumb>090568</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563835-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-AMGEN-TURSP2012047410</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563856-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563857-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563858-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP052660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEETH BRITTLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563867-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012047008</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, ONCE WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563868-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2012047267</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563869-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-AMGEN-ARGSP2012047956</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563870-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR010309</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTANON 250</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MUSCULAR WEAKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECA-DURABOLIN</medicinalproduct>
        <drugauthorizationnumb>13132</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULAR WEAKNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CREATINE</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MYOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563879-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-BAYER-2011-122053</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE IN PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLACENTA ACCRETA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563890-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE CERVIX STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563891-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077957</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EHH</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120731</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563892-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00C3A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563896-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563904-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010997</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563905-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-065961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>BA8635A</drugbatchnumb>
        <drugdosagetext>0.3 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563906-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>CA0791A</drugbatchnumb>
        <drugdosagetext>0.25 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563907-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.3 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugdosagetext>200-250, MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOCON</medicinalproduct>
        <drugdosagetext>1/35-28</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NALTREXONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN PREPARATION + MINERAL SUPPLEMENT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugdosagetext>5 MG, EC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563915-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>1.75 G, BID</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVANZ</medicinalproduct>
        <drugauthorizationnumb>021337</drugauthorizationnumb>
        <drugdosagetext>1 G, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563918-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351444USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER TRANSITIONAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE 0.05% CREAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENTHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>81099</drugauthorizationnumb>
        <drugdosagetext>AT A DOSE OF 15 MG/ EVERY WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563919-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-122883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PICOMILION</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-COMPLEX [VITAMIN B NOS]</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563920-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-048019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563921-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201025819NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563922-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-042048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>TACHYCARDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563923-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-040527</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURITIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILINA CLAV</medicinalproduct>
        <drugdosagetext>500 MG, 14 DISPENSED FOR 7 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070624</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS [VIT C,VIT H,MIN NOS,VIT PP,RETINOL,VIT E,VIT B</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563924-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-046805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AUTOIMMUNE RETINOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080829</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090417</drugenddate>
        <drugtreatmentduration>232</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081004</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090826</drugenddate>
        <drugtreatmentduration>327</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563932-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ABBOTT-12P-150-0951084-00</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVEDON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PRE FILLED PEN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PRE FILLED SYRINGE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563933-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA055297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563934-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1465</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>1464</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBANDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563936-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26302</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTURE WEARER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563937-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066393</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563938-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066520</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563939-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26039</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071203</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563940-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066569</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRIDOCYCLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXIC SKIN ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563941-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013743</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563942-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR057866</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCAPSULATION REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>020665</drugauthorizationnumb>
        <drugdosagetext>160 MG DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563943-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26351</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563944-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066570</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563945-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US009415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0169/F0175</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT SOFT TISSUE NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugbatchnumb>F0173</drugbatchnumb>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563946-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP061939</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563947-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26346</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563948-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563949-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066021</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563950-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26340</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563951-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012TR065559</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ELEVATED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPULSIVE HANDWASHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563952-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011BR42626</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARAGUCINA</medicinalproduct>
        <drugdosagetext>1 DF (UNK), DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugbatchnumb>20279</drugbatchnumb>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>1 DF (160 MG), QD (MORNING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF (70 MG), QW</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563953-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066623</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINGLE FUNCTIONAL KIDNEY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSENTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODOPINE BESYLATE AND VALSARTAN</medicinalproduct>
        <drugbatchnumb>0489</drugbatchnumb>
        <drugauthorizationnumb>021990</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563954-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26354</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563955-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US011029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN NEOPLASM OF ADRENAL GLAND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563956-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066529</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563957-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NZ061960</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, ONE TABLET PER NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML INFUSED OVER 30 MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOCLOBEMIDE</medicinalproduct>
        <drugdosagetext>150 MG, (ONE TABLET TWICE DAILY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, (ONE TABLET TWICE DAILY)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>47.5 MG, ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563958-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NZ059442</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563959-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IL066367</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563960-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU044855</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISPHOSPHONATES</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL WITH CALCIUM (COPACKAGED)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563961-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP061693</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SENNOSIDE A+B</medicinalproduct>
        <drugdosagetext>24 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugauthorizationnumb>50715</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563962-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066178</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563963-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066181</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563964-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG/100 ML, ONCE YEARLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563965-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010BR17292</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>4 DF (80 MG), PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>2 DF (80 MG), DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>2 DF (160 MG), DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMIN</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugindication>VENOUS OCCLUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.5 DF (120 MG), BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIOVENTRICULAR BLOCK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563966-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA066658</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>9.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563967-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066527</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563968-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26338</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL BACTERIAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070314</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090603</drugenddate>
        <drugtreatmentduration>813</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563969-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066523</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563970-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012CA003758</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VITREOUS FLOATERS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON OVERLOAD</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120111</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugauthorizationnumb>021882</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>1-2 TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563971-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NZ059441</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ADHESIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110119</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563972-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066207</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugdosagetext>TWO TIMES A DAY</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugauthorizationnumb>020831</drugauthorizationnumb>
        <drugindication>BRONCHIAL DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563973-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2010GB04506</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEAN CELL HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563974-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066792</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563975-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011JP67970</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>021560</drugauthorizationnumb>
        <drugdosagetext>1.75 MG, DAILY</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563976-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563977-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP26337</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>45 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060426</drugenddate>
        <drugtreatmentduration>211</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081015</drugenddate>
        <drugtreatmentduration>888</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISEDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050824</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563978-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA45320</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>50 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563979-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2011NL11251</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugdosagetext>480 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELOKEEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugdosagetext>360 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>420</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFACALCIDOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563980-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014936</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563981-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA29081</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563982-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066628</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEGALON</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOXICITY TO VARIOUS AGENTS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF (80MG VALS/ 12.5MG HCT), DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563983-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563984-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004107</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563985-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA055801</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563986-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012DE011229</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>160</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREAS TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLIC ACID</medicinalproduct>
        <drugauthorizationnumb>050791</drugauthorizationnumb>
        <drugdosagetext>720 MG, BID</drugdosagetext>
        <drugindication>PANCREAS TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>3.5 MG, BID</drugdosagetext>
        <drugindication>PANCREAS TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563987-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA066258</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563988-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066681</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG PER 100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110708</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG PER 100 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120731</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563989-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US07275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.503</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEREAVEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG HYPERINFLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSITIVITY OF TEETH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS NEUROSENSORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL CORD COMPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QW3</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563990-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066591</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PORIOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>13.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563991-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012ID066356</companynumb>
    <primarysource>
      <reportercountry>INDONESIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR ICTERUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOCARE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>PARACETAMOL 325 MG, TRAMADOL 375 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563992-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugdosagetext>4.6 MG, QD</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563993-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA046034</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563994-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563995-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA052474</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563996-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR066476</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVARIUS</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563997-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP064069</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>022083</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563998-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011AU116404</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG DAILY M.D.U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVANTAN</medicinalproduct>
        <drugdosagetext>APPLY 1ML NOCTE TO THE SCALP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>1/2 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROSONE OV</medicinalproduct>
        <drugdosagetext>APPLY NOCTE SPARINGLY, AND COVER WITH WARM DAMP TOWEL FOR 30 MINUTES</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NILSTAT</medicinalproduct>
        <drugdosagetext>1ML Q.I.D. AND HOLD IN THE MOUTH AS LONG AS POSSIBLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>HALF DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 MANE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1MG DAILY M.D.U.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3MG DAILY M.D.U</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVANTAN</medicinalproduct>
        <drugdosagetext>APPLY DAILY P.R.N</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugdosagetext>13.125MG/350.7MG/46.6MG/178.5MG 3 DAILY TO KEEP MOTIONS SOFT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPAN-K</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEBRIDOL</medicinalproduct>
        <drugdosagetext>2 Q.I.D PRN FOR PAIN OR FEVER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>1-2 DAILY PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, FIRST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE (NORSPAN)</medicinalproduct>
        <drugdosagetext>5MG (RELEASED AT 5MCG/HR) APPLY WEEKLY TO HAIRLESS SKIN OF UPPER BODY OR ARM</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN VITAMIN D</medicinalproduct>
        <drugdosagetext>1 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETNOVATE</medicinalproduct>
        <drugdosagetext>APPLY DAILY PRN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8563999-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US014160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT CREPITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FANCONI SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADRENAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL ALVEOLAR ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EDENTULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETERISATION CARDIAC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA DUE TO CARDIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOVENOUS FISTULA SITE COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOSTATIC HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIOPSY BONE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL EXAMINATION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTREMITY NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION VENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADDISON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOMA RECURRENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUTRA-PHOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRAMIDONE</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAMATINE</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENA-VITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTEF</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER</medicinalproduct>
        <drugdosagetext>1600 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN W/SULBACTAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXID</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYSOLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SURFAK</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEOCIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIRAMIDON</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL GENTLEHALER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSTIGMINE METHYLSULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMODIAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN                                /SCH/</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTEAL</medicinalproduct>
        <drugdosagetext>2 GTT, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.063 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>60 MG, RUN IN PHASE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAMICIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HYPERCALCAEMIA OF MALIGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010524</drugenddate>
        <drugtreatmentduration>1222</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTEAL LUBRICANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAYEXALATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564000-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066394</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>175 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090903</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564001-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NZ059213</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564002-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066471</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>1045</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564003-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NL040908</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0033</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, / 100ML ONCE IN 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0038</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, / 100ML ONCE IN 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0038</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, / 100ML ONCE IN 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0269</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, / 100ML ONCE IN 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0033</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, / 100ML ONCE IN 28 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564004-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR066691</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564005-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564006-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066483</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>2440</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564007-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA57415</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE SYSTOLIC INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
        <drugtreatmentduration>639</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564008-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015022</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564009-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>BONE NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564010-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2009CA40915</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREATH SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>METASTATIC CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091210</drugenddate>
        <drugtreatmentduration>141</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564011-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US00490</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER OUTLET OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS URETERIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO PELVIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGROWING NAIL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS BILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>150 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXANOL</medicinalproduct>
        <drugdosagetext>5 MG, Q4H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>UNK UKN, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIOSTAT</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564012-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA063323</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR INVASION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564013-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB001168</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL BELOW THERAPEUTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060306</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564014-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004275</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONIC ACID</medicinalproduct>
        <drugauthorizationnumb>21223</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BALSALAZIDE DISODIUM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564015-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012TW066144</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACANTHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PITYRIASIS ROSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564016-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012KR066519</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564017-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2008US07038</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL BONES FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSARCOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS MUCOSAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROANTRAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>3250 GY, TOTAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>2907</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>3000CGYS / TOTAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060704</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>20036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERTAPENEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEVACOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
        <drugdosagetext>3000CGYS / TOTAL</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060512</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINIDINE HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564018-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066695</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564019-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU048730</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564020-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>91</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOBI</medicinalproduct>
        <drugauthorizationnumb>050753</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugindication>BRONCHIECTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564021-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003647</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>12 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXOCOBALAMIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugauthorizationnumb>020823</drugauthorizationnumb>
        <drugdosagetext>6 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPNOTHERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564022-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066683</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564023-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012DE009351</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564024-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA029210</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564025-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004016</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564026-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564027-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MY052267</companynumb>
    <primarysource>
      <reportercountry>MALAYSIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugindication>GASTROINTESTINAL STROMAL TUMOUR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564028-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010CA16430</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>40 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>30 MG, QMO</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugdosagetext>100 UG, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugauthorizationnumb>019667</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUROENDOCRINE TUMOUR</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugdosagetext>30 MG EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564029-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066684</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564030-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NL054647</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL CORD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0008</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/100 ML SOLUTION 1X PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0008</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/100 ML SOLUTION 1X PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugbatchnumb>S0038</drugbatchnumb>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/100 ML SOLUTION 1X PER 28 DAYS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4MG/100 ML SOLUTION 1X PER 28 DAYS</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564031-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012KR063159</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TASIGNA</medicinalproduct>
        <drugauthorizationnumb>022068</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564032-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012IN066739</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMATINIB MESYLATE</medicinalproduct>
        <drugauthorizationnumb>021588</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564033-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA95756</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 2 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564034-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US12178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.912</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST LAMINECTOMY SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN ANALYSIS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES SIMPLEX SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXOPLASMA SEROLOGY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL OSTEODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER MOTOR NEURONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELITIS TRANSVERSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPSTEIN-BARR VIRUS ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIFE EXPECTANCY SHORTENED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BETA 2 MICROGLOBULIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-COMPLEX ^KRKA^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /UNK/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1500 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN ^GRUNENTHAL^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN HUMAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXANOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAALOX                                  /NET/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTRAMORPH PF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, Q6H</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMANTADINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAMORPH PF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIORESAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040617</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^ACHE^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, Q6H</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL ^RHONE-POULENC RORER^</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATHFLO ACTIVASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE W/VITAMIN D NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIOGLITAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIPIME</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564035-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US03401</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENCE JONES PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY HESITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCLONAL GAMMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORTHOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER WITHOUT AGORAPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISIONAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE FRAGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MG,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DISODIUM HYDROGEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HCL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>017</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugdosagetext>1 G, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564036-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2004US11591</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAMILY STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM CORONARY ARTERY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE MARROW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS DEFORMANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY LEAK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>UNK UKN, QW3</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VACCINE BREAST CANCER PROTOCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYBAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>30 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASLODEX</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020216</drugenddate>
        <drugtreatmentduration>667</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>2.5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030129</drugenddate>
        <drugtreatmentduration>867</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>4 MG/KG, LOADING DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, POST TAXOL INFUSION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, QD</drugdosagetext>
        <drugindication>OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVELBINE</medicinalproduct>
        <drugdosagetext>30MG/M2 UNKDAY1,8</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040204</drugenddate>
        <drugtreatmentduration>372</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugdosagetext>75 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIATION THERAPY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERALS NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPEUTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KYTRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>2 MG/KG, EVERY WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, Q3W</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050413</drugenddate>
        <drugtreatmentduration>414</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>20 MEQ, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>METASTASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000818</drugenddate>
        <drugtreatmentduration>120</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK UKN, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564037-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP060395</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSULFAN</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564038-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-2012SP031321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564039-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP060312</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>BONE MARROW CONDITIONING REGIMEN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugauthorizationnumb>050574</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564040-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201202899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>15 MG, Q 6 HOURS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXALGO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021217</drugauthorizationnumb>
        <drugdosagetext>12 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564041-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-AMGEN-IRLSP2012039363</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS ORBITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>2 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG/ML, ONE TIME DOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTRANS                            /00444002/</medicinalproduct>
        <drugdosagetext>16 MG, QWK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564046-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-UCBSA-061433</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HZT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110714</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564047-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16664BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564048-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2012R1-58561</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugauthorizationnumb>065113</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100813</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564049-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58613</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugauthorizationnumb>076045</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564050-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120528</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-RANBAXY-2012R1-56922</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>78734</drugauthorizationnumb>
        <drugdosagetext>900MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564051-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2012R1-58512</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>065062</drugauthorizationnumb>
        <drugdosagetext>200 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564052-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2012RR-58510</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>071214</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564053-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-RANBAXY-2012RR-58511</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>071214</drugauthorizationnumb>
        <drugdosagetext>UNK, 2/WEEK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564054-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58411</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>076990</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564055-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2012R1-58526</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>065062</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugauthorizationnumb>065062</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564056-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-RANBAXY-2012R1-58554</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>077542</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564057-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2012US-58505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>750 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OTITIS MEDIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugindication>CELLULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>20 MG,DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564058-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58417</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>10MG, 1X/DAY, NOCTE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>70MG, 2X/DAY (70MG, 2 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>076606</drugauthorizationnumb>
        <drugdosagetext>600/300/600</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>076606</drugauthorizationnumb>
        <drugdosagetext>300UNK, 3X/DAY (3 IN 1 D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564059-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-RANBAXY-2012R1-58562</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCLONIC EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>078734</drugauthorizationnumb>
        <drugdosagetext>22MG/KG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugauthorizationnumb>78734</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564060-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2012US-58491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>076786</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugauthorizationnumb>076786</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564061-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58580</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>40 DF</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>793</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564062-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-RANBAXY-2012RR-58218</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>077974</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL/HYDROCHLOROTIAZIDE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ISCHAEMIC STROKE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564063-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2012RR-58646</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KARDEGIC NOS</medicinalproduct>
        <drugdosagetext>75 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>130 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugdosagetext>6 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFENE RANBAXY 100MG COMPRIME PELLICULE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>076200</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2 G, UNK</drugdosagetext>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564064-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2009RR-23086</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIOTROPIUM DPI</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>76989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULPIRIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090309</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DANTROLENE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SALMETEROL XINAFOATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564065-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-57832</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564066-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-RANBAXY-2012R1-58560</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>078849</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE CORONARY SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>126</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOMETHASONE DIPROPIONATE</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUMETHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugauthorizationnumb>078849</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564067-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-RANBAXY-2011RR-41395</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXFOLIATIVE RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugauthorizationnumb>076285</drugauthorizationnumb>
        <drugdosagetext>40 MG QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564068-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-RANBAXY-2012RR-58675</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGOENCEPHALITIS HERPETIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564069-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-RANBAXY-2012US-58544</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>076606</drugauthorizationnumb>
        <drugdosagetext>900 MG, DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMCR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564071-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564072-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-015041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, EVERY 12 HOURS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN VK</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564073-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-032677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>875/125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564074-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564075-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-041006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>83709A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564076-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-024552</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.342</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>33 MG,100/ML, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564077-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-028774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANOS</medicinalproduct>
        <drugdosagetext>0.1 %, UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugdosagetext>180 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
        <drugtreatmentduration>637</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564078-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201017353NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.636</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>488</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>427</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564079-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-024546</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.224</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE W/CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>84579A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100407</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100407</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564080-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201020595NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.909</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>PHARMACY RECORDS: YAZ WAS REFILLED ON 07 MAY 2007, 06 JUN 2007 AND 27 JUN 2007.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070706</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564081-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076107</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.998</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>2 MG HS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111020</drugenddate>
        <drugtreatmentduration>1332</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>40 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1.5 MG, HS (INTERPRETED AS HOURS OF SLEEP) PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG BEDTIME PRN (INTERPRETED AS NEEDED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
        <drugtreatmentduration>1067</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110628</drugenddate>
        <drugtreatmentduration>1295</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100628</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>5 MG/325MG [EVERY] 4 H/PRN (INTERPRETED AS HOURS AS NEEDED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100903</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564082-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201022369NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EROSIVE OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080510</drugenddate>
        <drugtreatmentduration>730</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564083-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-040005</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, THREE TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090526</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>90 ?G, INHALATION</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>60 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRILHYDROCHLOROTHIAZIDE RATIOPHARM</medicinalproduct>
        <drugdosagetext>10-12.5</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.25 MG, TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN FE 1/20</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564084-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-016827</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031021</drugenddate>
        <drugtreatmentduration>379</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564085-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-066448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.562</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugdosagetext>50 UNK, UNK</drugdosagetext>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNICEF</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564086-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-042297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>164</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060828</drugenddate>
        <drugtreatmentduration>783</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>UTERINE HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071211</drugenddate>
        <drugtreatmentduration>239</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060419</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564087-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-003397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>107.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>POLYCYSTIC OVARIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564088-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2010US03465</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DEVIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL CAVITY FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564092-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008674</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081001</drugenddate>
        <drugtreatmentduration>2653</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564093-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1102USA02276</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE LACK OF</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAMMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LORDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>3650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564096-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-GENZYME-POMP-1001663</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>20</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYOZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>20 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564097-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1002624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>0.92 MG/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564098-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GENZYME-THYM-1003349</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THYMOGLOBULIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>190 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100906</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOPRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS-RESISTANT LACTIC ACID BACTERIAE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110312</drugenddate>
        <drugtreatmentduration>300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100620</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEFERASIROX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101124</drugenddate>
        <drugtreatmentduration>154</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100605</drugenddate>
        <drugtreatmentduration>236</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE SODIUM SUCCINATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100521</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOGRASTIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>APLASTIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100605</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBAZOCHROME SODIUM SULFONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HAEMORRHAGE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564099-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-GENZYME-CLOF-1002233</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>UNK, FROM DAY 1 TO 10</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOFARABINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021673</drugauthorizationnumb>
        <drugdosagetext>17 MG AT DAY 2, 4, 6, 8, 10, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IDARUBICIN HCL</medicinalproduct>
        <drugdosagetext>17 MG AT DAY 1, 3, 5</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564100-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201011579NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58.957</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SUPERINFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050919</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060502</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564106-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-041123</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45.805</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATORENAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KERATINAMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564107-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16550BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564108-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16556BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564109-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-US-EMD SERONO, INC.-7150328</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOROSEL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAFRANIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALOSPIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564110-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7150142</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002664</drugbatchnumb>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564111-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-US-EMD SERONO, INC.-7149409</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564112-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7149682</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564113-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-US-EMD SERONO, INC.-7149774</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564114-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-US-EMD SERONO, INC.-7148634</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DAYDREAMING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL CONDITION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>DOSAGE INCREASED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTERFERON BETA NOS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564115-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-12US005044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.982</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugbatchnumb>2CE0807</drugbatchnumb>
        <drugauthorizationnumb>072096</drugauthorizationnumb>
        <drugdosagetext>400 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XODOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564116-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564117-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EE3</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564118-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-201046823GPV</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPRAVENTRICULAR TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100307</drugenddate>
        <drugtreatmentduration>87</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>240 MG (DAILY DOSE), , ORAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564119-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-068070</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTI FACTOR VIII ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECOMBINATE</medicinalproduct>
        <drugdosagetext>1 TO 2 TIMES/MONTH</drugdosagetext>
        <drugindication>HAEMARTHROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECOMBINATE</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOGENATE FS</medicinalproduct>
        <drugbatchnumb>27N2X23</drugbatchnumb>
        <drugdosagetext>1 TO 2 TIMES/MONTH</drugdosagetext>
        <drugindication>HAEMARTHROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564120-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-VERTEX PHARMACEUTICALS INC.-000000000000000996</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPHOSPHATAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNKNOWN</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugbatchnumb>NOT AVAILABLE</drugbatchnumb>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: INJECTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564121-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564122-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP031878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugbatchnumb>BK0367978</drugbatchnumb>
        <drugauthorizationnumb>022518</drugauthorizationnumb>
        <drugdosagetext>100 MICROGRAM, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>OIN/ALLEGRA</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>XR</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564123-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009052</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>4 DF, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 MICROGRAM, UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564127-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GE HEALTHCARE MEDICAL DIAGNOSTICS-OPTN-PR-1207S-0015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACK OF SPONTANEOUS SPEECH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTISON</medicinalproduct>
        <drugbatchnumb>2005</drugbatchnumb>
        <drugauthorizationnumb>020899</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYNCOPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPTISON</medicinalproduct>
        <drugbatchnumb>2005</drugbatchnumb>
        <drugauthorizationnumb>020899</drugauthorizationnumb>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564134-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2012048333</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>52</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTINE</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA - KHK</medicinalproduct>
        <drugdosagetext>60 MUG, Q4WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA - KHK</medicinalproduct>
        <drugdosagetext>60 MUG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA - KHK</medicinalproduct>
        <drugdosagetext>120 MUG, Q4WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA - KHK</medicinalproduct>
        <drugdosagetext>60 MUG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EVIPROSTAT N</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREMEZIN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLOMERULONEPHRITIS CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONIEL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA - KHK</medicinalproduct>
        <drugdosagetext>30 MUG, Q2WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111208</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA - KHK</medicinalproduct>
        <drugdosagetext>60 MUG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564142-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564143-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564144-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>CBB4H00</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564145-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564146-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20120715253</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL MALFORMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>FOETAL EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564147-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712966</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564148-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120715349</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564149-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120715372</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564150-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714568</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564151-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713192</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564152-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714512</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564153-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714048</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DELUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PARANOIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564154-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712554</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYRINGE ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564155-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120701299</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED AT INAPPROPRIATE SITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AMYOTROPHIC LATERAL SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SOCIAL PHOBIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564156-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713685</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLIPAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564157-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-JNJFOC-20120714384</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHORIOAMNIONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>0, 2 AND 6 AND SUBSEQUENTLY EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564158-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120714463</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120802</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564159-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713832</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>8/52 (UNITS UNSPECIFIED)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIGAN</medicinalproduct>
        <drugdosagetext>UNITS: GTTS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugdosagetext>TWO IN MORNING, ONCE IN THE EVENING AND TWICE AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>DOSAGE: 1.5 ONCE DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE E</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SCOPOLAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugdosagetext>400/500MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>GTTS HS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564160-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120714439</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564161-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PURDUE-USA-2012-0090335</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILODOSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564163-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA003579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANOSMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugauthorizationnumb>020762</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564164-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MSD-2012SP029252</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>022277</drugauthorizationnumb>
        <drugdosagetext>120 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLIOBLASTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120122</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564165-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>323</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564166-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1109USA03018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVARIAN MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS PYROPHOSPHATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DILATATION ATRIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NODULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INNER EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIASTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70  MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>3997</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>5840</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564168-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-042205</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>10 MG 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>DOSE: 10 MG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUPIRTINE MALEATE</medicinalproduct>
        <drugdosagetext>100 MG, 1-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, 0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPINE</medicinalproduct>
        <drugdosagetext>20 MG;  0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG 1-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>25 MG, 0-0-0-1</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
        <drugtreatmentduration>407</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG 1-0-0</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG,</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugdosagetext>10 MG, 1-0-0</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564169-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PURDUE-USA-2012-0087649</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021745</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564171-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUSP2012037542</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QWK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONVIVA                            /01304701/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>60 MG, Q6MO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
        <drugtreatmentduration>190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564172-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-MPIJNJ-2012-05254</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM FORTE EU RHO</medicinalproduct>
        <drugdosagetext>980 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALGIN                           /00169801/</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KATADOLON                          /00890102/</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCALTROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOZOL                           /01263202/</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564173-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MILLENNIUM PHARMACEUTICALS, INC.-2012-05177</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564174-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-MPIJNJ-2012-05180</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564175-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-MPIJNJ-2012-05382</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR LYSIS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>UNK MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>DIFFUSE LARGE B-CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>400 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564176-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-MPIJNJ-2012-05378</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOTIC THROMBOCYTOPENIC PURPURA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>375 UNK, UNK</drugdosagetext>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>90 MG/M2, UNK</drugdosagetext>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564177-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120624</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-MILLENNIUM PHARMACEUTICALS, INC.-2012-04500</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564178-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS A</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564179-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564180-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20120715317</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>10TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>CYCLICAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564181-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715272</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564182-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120715361</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564183-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715258</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>0, 2, 6 AND 8 WEEKS  FIRST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564184-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715240</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564185-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715148</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564186-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715169</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>RECEIVING INDUSTION DOSES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564187-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715178</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTIFOAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564188-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-VERTEX PHARMACEUTICALS INC.-000000000000001301</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugbatchnumb>365764</drugbatchnumb>
        <drugauthorizationnumb>71832</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugbatchnumb>365765</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: INJECTION</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC STEATOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: CAPSULE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC STEATOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCTOZORIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANAL PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugbatchnumb>365765</drugbatchnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
        <drugdosagetext>800 DROPS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC STEATOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC STEATOSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564190-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009302</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2562</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2562</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564191-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961550-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>BONE PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564192-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0944022-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCISION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPAFLO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564193-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959918-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPLIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>140762E</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>1 DAILY, NOT SURE OF DOSE</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPLIN</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564194-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE41555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>761</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITROPAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564195-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0962525-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>88058</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564196-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961717-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEOSTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>(160 MG, LOADING DOSE)</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564197-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LB-ABBOTT-12P-093-0962851-00</companynumb>
    <primarysource>
      <reportercountry>UNITED ARAB EMIRATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564198-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959257-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DOES NOT KNOW TAKING IT EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564199-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0957142-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6019933</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564200-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951088-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINDOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564201-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2010002510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIQUID PRODUCT PHYSICAL ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>1030095</drugbatchnumb>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564202-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17354BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120731</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACE INHIBITOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564203-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20120715216</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>(LOADING INFUSIONS AT WEEK 0, 2, 6, MAINTENANCE INFUSIONS EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564204-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20120800657</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>(LOADING INFUSIONS AT WEEK 0, 2, 6, MAINTENANCE INFUSIONS EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564205-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20120800656</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>(LOADING INFUSIONS AT WEEK 0, 2, 6, MAINTENANCE INFUSIONS EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564206-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120800271</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564207-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120702369</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564208-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER STAGE IV</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564209-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564210-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>81161A</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080911</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564211-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-027691</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF DEVICE INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00DAK</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564212-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20101116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201047316GPV</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OLIGOHYDRAMNIOS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>TITRATED TO DISCONTINUATION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>CONTINUOUS INTRAVENOUS INFUSIONS 6.6 MG/KG/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DACARBAZINE</medicinalproduct>
        <drugauthorizationnumb>017575</drugauthorizationnumb>
        <drugdosagetext>ON DAYS 20, 34, 54, 68, AND 80</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>TITRATED TO DISCONTINUATION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINBLASTINE SULFATE</medicinalproduct>
        <drugdosagetext>ON DAYS 20, 34, 54, 68, AND 80</drugdosagetext>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>CONTINUOUS INTRAVENOUS INFUSIONS 9 MG/KG/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>CONTINUOUS INTRAVENOUS INFUSIONS 7.5 MG/KG/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>ON DAYS 20, 34, 54, 68, AND 80</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>CONTINUOUS INTRAVENOUS INFUSIONS 2.4 MG/KG/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugindication>FUNGAEMIA</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>CONTINUOUS INTRAVENOUS INFUSIONS 3 MG/KG/H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN/TAZOBACTAM</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LINEZOLID</medicinalproduct>
        <drugindication>PNEUMONIA</drugindication>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugdosagetext>MAXIMUM INFUSION RATE OF 10 MG/H</drugdosagetext>
        <drugindication>SEDATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564213-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-2012-052139</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110310</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111023</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111029</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111113</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111215</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 112.5 ?G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD THYROID STIMULATING HORMONE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110520</drugenddate>
        <drugtreatmentduration>149</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 100 ?G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111102</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 100 ?G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120110</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 112.5 ?G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120412</drugenddate>
        <drugtreatmentduration>93</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 112.5 ?G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1000 MG</drugdosagetext>
        <drugindication>BREAST MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>47280020</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>47280020</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD, CYCLE 18</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>47280020</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD, CYCLE 19</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>47280020</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD, CYCLE 20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 125 ?G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST PROCEDURAL HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101222</drugenddate>
        <drugtreatmentduration>1461</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 75 ?G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111217</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110511</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120130</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>47280020</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>21923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101220</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110110</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110407</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110602</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110626</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED SORAFENIB (RAF KINASE INHIBITOR)</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110925</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEPARINA</medicinalproduct>
        <drugdosagetext>DAILY DOSE .4 ML</drugdosagetext>
        <drugindication>BREAST MASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120221</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564214-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100623</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-200941467NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIARY DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYCOLOG</medicinalproduct>
        <drugdosagetext>11100000-0.1 U/GM-% CREA. 14-DEC-2004</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORTHO NOVIN</medicinalproduct>
        <drugdosagetext>1/35</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070430</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>03-NOV-2005</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>14-DEC-2004</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIOTHIXENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
        <drugtreatmentduration>182</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090815</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS [VIT C,VIT H,MIN NOS,VIT PP,RETINOL,VIT E,VIT B</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICROGESTIN 1.5/30</medicinalproduct>
        <drugdosagetext>1.5-30 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564217-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SHIRE-ALL1-2012-03606</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>10</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINE ODOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAPRASE</medicinalproduct>
        <drugbatchnumb>FDD12-013</drugbatchnumb>
        <drugdosagetext>24 MG, 1X/WEEK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MUCOPOLYSACCHARIDOSIS II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564218-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BG-AMGEN-BGRSP2012048009</companynumb>
    <primarysource>
      <reportercountry>BULGARIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTINEOPLASTIC AGENTS</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>500 MG, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564219-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011014784</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>158.46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOAFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS INADEQUATE CONTROL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NARCISSISTIC PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALEX</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYLIRA</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORIATANE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLUX</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>1 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANUSOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, 2 TIMES/WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL 0.05%</medicinalproduct>
        <drugdosagetext>UNK UNK, BID</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>110 IU, BID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>50 IU, BID</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN LISPRO</medicinalproduct>
        <drugdosagetext>25 IU, AC</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564220-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12023077</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIMPIDEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
        <drugtreatmentduration>265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>4000 IU (INTERNATIONAL UNIT)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
        <drugtreatmentduration>265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111114</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
        <drugtreatmentduration>265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564221-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120705420</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>11F041MG</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>11F041MG</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>11F041MG</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564222-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20120713097</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA INFECTIOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAEROBEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROINTESTINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROINTESTINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564223-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120610540</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN;UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN;UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564224-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120714905</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREDININ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564225-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120604194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564226-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20120307605</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564227-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120712579</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AUTISM SPECTRUM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AUTISM SPECTRUM DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564228-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>RANGE 5-75 G</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN WITH PROPOXYPHENE HCL TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564229-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20120713347</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLASMIN INHIBITOR INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMINOGEN ACTIVATOR INHIBITOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APAP TAB</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564230-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564231-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120713197</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>19872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564232-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20120711952</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564233-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-JNJFOC-20120801218</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564234-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20120713336</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTENTIONAL SELF-INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564235-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120706128</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564236-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120711608</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564237-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711579</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>1202176P1</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564238-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120712247</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564239-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120613626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT COATING ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURN OESOPHAGEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT SOLUBILITY ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INTELENCE</medicinalproduct>
        <drugbatchnumb>BKL3500</drugbatchnumb>
        <drugauthorizationnumb>022187</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUZEON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564240-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHIAL SECRETION RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER IN SITU</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>2.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>407</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110526</drugenddate>
        <drugtreatmentduration>407</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564241-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012592</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>50742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STROMECTOL</medicinalproduct>
        <drugauthorizationnumb>050742</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564242-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR002179</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CSF PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564243-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA010026</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFECTIOUS PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHIMAX (COLCHICINE (+) DICYCLOMINE HYDROCHLORIDE)</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110808</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110808</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>1.5 MICROGRAM PER KILOGRAM, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110808</drugenddate>
        <drugtreatmentduration>110</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MICROGRAM, QD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564244-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-009507513-1108USA01132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARRETT'S OESOPHAGUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS STENOSANS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENOSYNOVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE MALUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE V HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENOPAUSAL SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050426</drugenddate>
        <drugtreatmentduration>1091</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564246-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>2012SP002135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATUDA</medicinalproduct>
        <drugauthorizationnumb>200603</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564247-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120705264</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGLAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM CAP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>1 TABLET 5 TIMES A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugdosagetext>1 TABLET 5 TIMES A DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564249-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120707422</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>017463</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564250-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564251-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120511751</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-ECLAMPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG MANE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG MANE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETIME HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETIME HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564252-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120609038</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564253-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120604600</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>93</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEMANTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>021169</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTELUKAST SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564254-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120301781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>FOR UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50718</drugauthorizationnumb>
        <drugdosagetext>FOR UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>FOR UPTO 6 CYCLES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564255-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20120800659</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA AREATA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>(LOADING INFUSIONS AT WEEK 0, 2, 6, MAINTENANCE INFUSIONS EVERY 8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>8564256-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120712906</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLOSSOPTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564257-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120712941</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GLOSSOPTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>1 TO 3 MG/KG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564258-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20110608634</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION RATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, AUDITORY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564259-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2012-046092</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOLYTIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564260-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-003878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>AA2693A</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564261-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-003693</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564262-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAYER-2012-077432</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564263-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-028127</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>123</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugbatchnumb>91634A</drugbatchnumb>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564264-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-201024988NA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.678</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METABOLIFE</medicinalproduct>
        <drugdosagetext>UNK UNK, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080825</drugenddate>
        <drugtreatmentduration>852</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUGS FOR FUNCTIONAL GASTROINTEST. DISORDERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCYAMINE</medicinalproduct>
        <drugdosagetext>0.125 MG, PRN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564265-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-013028</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.703</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG,ONE TABLET ONE HOUR BEFORE SURGERY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG,  EVERY 12 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUID RETENTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090307</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPERIDINE HCL</medicinalproduct>
        <drugdosagetext>50 MG, TAKE ONE EVERY 4 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugdosagetext>750 MG, BID AFTER SURGERY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXISTAD [AMOXICILLIN TRIHYDRATE,CLAVULANATE POTASSIUM]</medicinalproduct>
        <drugdosagetext>875 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>40 MG, TAKE ONCE CAPSULE, ONE HOUR PRIOR TO SURGERY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564269-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120713106</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE STRANDED DNA ANTIBODY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564270-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-JNJFOC-20120715366</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AULIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564271-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713665</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS POSTMENOPAUSAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564272-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713813</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.16</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPENDICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564273-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713109</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-CORTEF</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>ONCE IN 6-8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564274-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714515</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564275-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714563</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564276-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564277-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714619</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRANIOCEREBRAL INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564278-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715384</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564279-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564280-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACIAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>EVERY OTHER MONTH</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564281-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564282-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS LISTERIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564283-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.95</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564284-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120402460</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>125</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564285-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20120714001</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564286-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20120714107</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugdosagetext>FOR 9 MONTHS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564287-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120715107</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564288-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713227</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugdosagetext>234 MG/156 MG INITIATION DOSES</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564289-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2012SA054393</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULORIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>016273</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564292-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120524</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120519262</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugbatchnumb>0241D3A</drugbatchnumb>
        <drugauthorizationnumb>021812</drugauthorizationnumb>
        <drugdosagetext>1/2 CAPFUL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOXIDIL</medicinalproduct>
        <drugbatchnumb>0241D3A</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564293-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120705919</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHALAMO-PITUITARY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE EXTRA STRENGTH (FOR MEN)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROGAINE EXTRA STRENGTH (FOR MEN)</medicinalproduct>
        <drugauthorizationnumb>020834</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564294-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20120314129</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111026</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564295-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20120513098</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564296-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120711570</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LACUNAR INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564297-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120703791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLON CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>17 INJECTIONS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>USE FOR MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugdosagetext>2ND INJECTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PYODERMA GANGRENOSUM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugdosagetext>1ST INJECTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564298-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120606873</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564299-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20111105057</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APO-KETO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIDEX (EYE DROPS)</medicinalproduct>
        <drugdosagetext>EVERY 2 HOURS DAY TIME</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EYE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>EVERY 1 HOUR X 48 HOURS, EVERY 2 HOUR THEREAFTER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564300-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120110100</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCLEAR MAGNETIC RESONANCE IMAGING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564301-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-JNJFOC-20120406645</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX HAEMORRHAGE UTERINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564302-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714581</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564303-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE DISORDER</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
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    </patient>
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  <safetyreport>
    <safetyreportid>8564304-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
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    <receiptdate>20120724</receiptdate>
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      <reportercountry>MOROCCO</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
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    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
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    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE LYMPHOCYTE PREDOMINANCE STAGE I SITE UNSPEC</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040603</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031008</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111227</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONEALFA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>51ST INFUSION  300 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091005</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPALMON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL COLUMN STENOSIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091130</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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  <safetyreport>
    <safetyreportid>8564306-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120514087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>66.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050908</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
    </patient>
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  <safetyreport>
    <safetyreportid>8564307-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120612314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>86.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC FOOT INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORTICOSTEROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
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  <safetyreport>
    <safetyreportid>8564308-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120700397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>43.55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC NECK SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>HAEMOGLOBIN DECREASED</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
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        <drugenddate>20120511</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
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    <safetyreportid>8564309-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
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    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG CYST</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>JOINT ARTHROPLASTY</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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  <safetyreport>
    <safetyreportid>8564310-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120104133</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
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      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PATELLA FRACTURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
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        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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        <drugstartdate>20030203</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030206</drugstartdate>
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        <drugenddate>20111223</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
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  <safetyreport>
    <safetyreportid>8564311-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <serious>1</serious>
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    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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      <reportercountry>CANADA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
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        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
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        <drugstartdate>20110101</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
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    <safetyreportid>8564312-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <receivedateformat>102</receivedateformat>
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      <reportercountry>CANADA</reportercountry>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
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        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DENTAL OPERATION</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>APPROXIMATELY 26 INFUSIONS RECEIVED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
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    <safetyreportid>8564313-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20111001358</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
        <drugdosagetext>HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>BEFORE NOON</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>33 INFUSIONS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564314-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20120406563</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>4TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564315-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120605446</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IRMA63802;BGF40501301 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IRMA63802;BGF40501301 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IRMA63802;BGF40501301 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564316-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-JNJFOC-20120707156</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>21ST INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564317-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120613780</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564318-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120303940</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UVEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070816</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564319-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP013381</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012): FORMULATION: POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012): FORMULATION: POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.2MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.0 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.2MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120416</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120325</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.5 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012): FORMULATION: POR, FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012): FORMULATION: POR, FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.0MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120129</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>0.8 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120206</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROTYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.2 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120129</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITAVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012): FORMULATION: POR, FREQUENCY, STOP DATE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012): FORMULATION: POR, FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.0MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012): FORMULATION: POR, FREQUENCY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugdosagetext>UPDATE (07MAY2012)</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.8MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.0 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564320-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564321-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73.016</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugauthorizationnumb>021920</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANOTHER DIABETIC PILL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564322-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564323-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564324-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564325-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076793</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564326-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564327-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564328-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564329-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564330-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076866</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564331-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564332-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076031</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564333-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113.38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564334-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076567</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564335-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-040255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091107</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVIRALS FOR SYSTEMIC USE</medicinalproduct>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVIRALS FOR SYSTEMIC USE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564336-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564337-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076877</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564338-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076795</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564339-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564340-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-105714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROAMPHETAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091028</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>137 MCG/24HR, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564341-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EUPHORIC MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564342-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564343-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.295</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>3 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564346-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076221</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>NAA04L1</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC MEDICATION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>NAA04L1</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION (NOS)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564348-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076603</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564349-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076430</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564350-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>200533</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MAJOR DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugauthorizationnumb>22304</drugauthorizationnumb>
        <drugdosagetext>EVERY 4-6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564351-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120519314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA</medicinalproduct>
        <drugauthorizationnumb>022304</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564352-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713719</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugauthorizationnumb>200533</drugauthorizationnumb>
        <drugdosagetext>2 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>3 PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCYNTA ER</medicinalproduct>
        <drugdosagetext>2 TIMES A DAY FOR 7X10 DAYS WITH A PROVISION FOR 50 MG BID TITRATION EVERY 5 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564353-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120607908</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADIZEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROSALIC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOVOBET</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMOLLIENTS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMOVATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564354-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120701951</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSIVE SYMPTOM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TOOTH INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564355-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120407576</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugdosagetext>THE START DATE WAS MORE THAN 15 YEARS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110104</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564356-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120714123</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>2 DF X 1 PER 1 DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564357-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2012SA053393</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KERLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019507</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564358-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTELLAS-2012EU005343</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>0.1 MG/KG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564359-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>3.5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564360-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ASTELLAS-2012US006495</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER REPAIR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE FOR UNAPPROVED INDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564361-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564362-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTELLAS-2012EU005356</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIFENACIN SUCCINATE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564363-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012US006283</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>25 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>25 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>25 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>25 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564364-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTELLAS-2012US006075</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED OSI-906</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVEENO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH PRURITIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED OSI-906</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>1 %, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPROBASE                          /01132701/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564365-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP005826</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UMBILICAL CORD AROUND NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW BIRTH WEIGHT BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APGAR SCORE LOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE DURING BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EXPOSURE DURING BREAST FEEDING</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>FOETAL EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>2 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>FOETAL EXPOSURE DURING PREGNANCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
        <drugtreatmentduration>184</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>1 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120210</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>3 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>EXPOSURE DURING BREAST FEEDING</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564366-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00943UK</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAJENTA</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEFT VENTRICULAR FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564367-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-UK-00989UK</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE/LAMIVUDINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564368-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AU-01322AU</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAJENTA</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564369-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564370-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTELLAS-2012EU005363</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GINGIVAL HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564371-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564372-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005844</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEXISCAN</medicinalproduct>
        <drugbatchnumb>7-034-EV</drugbatchnumb>
        <drugauthorizationnumb>022161</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SCAN MYOCARDIAL PERFUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564373-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012JP007033</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564375-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564376-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP004520</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILIARY COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>248</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564377-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564378-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2011US003980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050777</drugauthorizationnumb>
        <drugdosagetext>0.1 %, WEEKLY</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DERMATITIS ATOPIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564379-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006593</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>500 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564380-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012US004629</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564381-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTELLAS-2012US006613</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CREATININE RENAL CLEARANCE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>80 MG, UNKNOWN/D</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugdosagetext>11 CYCLES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>279 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugdosagetext>125 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
        <drugtreatmentduration>703</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULASTA</medicinalproduct>
        <drugdosagetext>6 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugdosagetext>80 MG, UNKNOWN/D</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>765 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPHREN                            /00955302/</medicinalproduct>
        <drugdosagetext>8 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564382-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTELLAS-2012US006637</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110526</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564383-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ASTELLAS-2012EU005403</companynumb>
    <primarysource>
      <reportercountry>European Union</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>650 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>1500 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564384-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUPUS-LIKE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIIN C</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERREX FORTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ-10</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEART TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
        <drugtreatmentduration>662</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D                /01483701/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564385-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17368BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564386-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564387-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006592</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPICE CARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564388-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTELLAS-2012EU005433</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL HYPOPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>FOETAL EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>75 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>FOETAL EXPOSURE DURING PREGNANCY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564389-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugbatchnumb>TS003</drugbatchnumb>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK, 3-5 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, UID/QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>10 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564390-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012US006642</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120216</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>800 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>800 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>800 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYDOXAL</medicinalproduct>
        <drugdosagetext>60 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>100 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>800 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>800 MG/M2, UID/QD</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBOFLAVIN TAB</medicinalproduct>
        <drugdosagetext>20 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564391-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2011US006349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BILE DUCT OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIRUBIN CONJUGATED INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>600 MG/M2, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>75 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GDC-0449</medicinalproduct>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GDC-0449</medicinalproduct>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>600 MG/M2, WEEKLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110923</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>21743</drugauthorizationnumb>
        <drugdosagetext>75 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BILE DUCT CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564392-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugauthorizationnumb>021518</drugauthorizationnumb>
        <drugdosagetext>5 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564393-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US005741</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN          /01430901/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugindication>TRACHEAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564394-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564395-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564396-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTELLAS-2012US006610</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS                           /90003601/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>150 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564397-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRASP2012041092</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENITAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100928</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>550 MG DAILY INTERMITTENTLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMALINE                           /00764901/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564398-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>092852E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564399-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957510-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HISTOPLASMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>102322E</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>102322E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564400-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0962978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564406-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120703735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564407-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120703979</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIC PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
        <drugauthorizationnumb>015923</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564408-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIATION PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>1MG307</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>1MG307</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19850101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564410-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120708754</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564411-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564412-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564413-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>5</patientonsetage>
      <patientonsetageunit>800</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564414-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120713910</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMAL SALINE SOLUTION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>POSTOPERATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugdosagetext>NOVALGINA</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564415-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OBESITY SURGERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugauthorizationnumb>020193</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564416-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120712194</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>29</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564417-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077408</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BIPOLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564418-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>3 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564419-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076858</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564421-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076688</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564422-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564423-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076781</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564424-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075998</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564425-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL'S</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564426-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075638</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564427-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564428-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-072131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugbatchnumb>NAA09NN</drugbatchnumb>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugdosagetext>2 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564429-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564430-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564431-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-BAYER-2012-058715</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHRODERMIC PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUSTULAR PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>393</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564432-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078292</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOPEDIC PROCEDURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564433-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-CELGENEUS-013-21880-12053349</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>80 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY EXTRACT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACODEINE</medicinalproduct>
        <drugdosagetext>1 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>2000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>2.8571 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>4 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETAVLEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOVENT</medicinalproduct>
        <drugdosagetext>1 OTHER</drugdosagetext>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110616</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>80 GRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>R CALM CREME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED BLOOD CELLS</medicinalproduct>
        <drugdosagetext>1</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>THROMBOCYTOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATELETS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>2.8571 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHOLE BLOOD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANCYTOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACODEINE</medicinalproduct>
        <drugdosagetext>.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564434-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-OPCR20121617</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>201655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>201655</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INTERVERTEBRAL DISC DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564435-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-PERC20120118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>040330</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564436-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-OPER20120715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OPANA ER</medicinalproduct>
        <drugauthorizationnumb>021610</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564440-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077874</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564441-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710526</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL-500</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>650MG/CAPLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564442-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012185743</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564443-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011022350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.061</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE COMPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KADIAN</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BURNING SENSATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>10/250 MG, 4X/DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugauthorizationnumb>018565</drugauthorizationnumb>
        <drugdosagetext>30 MG, 2X/DAY</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1MG THREE OR FOUR TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STRESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564444-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012185538</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>MAXIMUM OF 1 VIAL (INTAKE NOT PROVEN)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564445-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012185680</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564446-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012184171</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564447-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012184246</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG (ONE CAPSULE), 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564448-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-PFIZER INC-2012184578</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564449-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-SANOFI-AVENTIS-2012SA052495</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564450-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MICROGRAM/0.5ML, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564451-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19830201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-83040111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012704</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564452-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA010893</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>022277</drugauthorizationnumb>
        <drugdosagetext>260 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564453-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA053676</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPARIN-INDUCED THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020164</drugauthorizationnumb>
        <drugdosagetext>DOSE 2000 IU/L</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564454-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-SANOFI-AVENTIS-2012SA052507</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE MB INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>2365</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090120</drugenddate>
        <drugtreatmentduration>47</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564455-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-AMGEN-COLSP2012043607</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTRIMAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROQUINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564456-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564457-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564458-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-348034</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARATHYROID TUMOUR BENIGN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OBESITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564459-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-NOVOPROD-352451</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG (3 TABLETS/DIE)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 (2 TABLETS/DIE)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG/DIE, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110720</drugenddate>
        <drugtreatmentduration>180</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG (3 TABLETS/DIE)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>3000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>1 TABLET/EVERY 18 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>1 TABLET/DIE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG (3 TABLETS/DIE)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>1 TABLET/DIE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090923</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>500 MG 2 TABLETS/DIE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>2 TABLETS/DIE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564460-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-NOVOPROD-356628</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEPHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20986</drugauthorizationnumb>
        <drugdosagetext>8U IN THE MORNING AND 8U IN THE EVENING</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020986</drugauthorizationnumb>
        <drugdosagetext>8U IN THE MORNING, 4U AT NOON AND 4U IN THE EVENING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564461-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-NOVOPROD-330529</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 UG, QD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>2.0 UG, QD</drugdosagetext>
        <drugindication>VITAMIN B12 DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOSMIN</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugindication>VENOUS INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110603</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>14 IU, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '125'</medicinalproduct>
        <drugdosagetext>1 U, QD</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110615</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>90 MG, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM POLYSTYRENE SULFONATE</medicinalproduct>
        <drugdosagetext>30 G, QD</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>400 UG, QD</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIDROFEROL</medicinalproduct>
        <drugdosagetext>0.2 MG, QD</drugdosagetext>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564462-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-NOVOPROD-351888</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564463-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-NOVOPROD-351796</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3</patientweight>
      <reaction>
        <reactionmeddrapt>PLACENTAL INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC ISLETS HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROSOMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>FROM 8 IU TO 18 IU BEFORE EACH MEAL</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 G, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>18 IU, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>GESTATIONAL DIABETES</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019959</drugauthorizationnumb>
        <drugdosagetext>20 IU IN MORNING, 20 IU IN EVENING</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564464-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-NOVOPROD-356646</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN FLEXPRO</medicinalproduct>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>0.1 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORDITROPIN FLEXPRO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021148</drugauthorizationnumb>
        <drugdosagetext>0.1 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564465-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-NOVOPROD-346906</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>114</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>3 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPEN                            /00340101/</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>2 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 TAB, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>AS64697</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564466-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SG-NOVOPROD-356251</companynumb>
    <primarysource>
      <reportercountry>SINGAPORE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REPAGLINIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020741</drugauthorizationnumb>
        <drugdosagetext>5 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100923</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100923</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVODOPA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564467-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-NOVOPROD-354859</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>0.6 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111211</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>1.2 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564468-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVOPROD-356485</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022341</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>7.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564469-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-058661</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE, BATCH NO: UNKNOWN</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE:7.5</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>SINGLE DOSE:15</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564470-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-2012-077622</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.422</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEOSALDINA</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE/DIENOGEST</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATIC PREPARATION</medicinalproduct>
        <drugdosagetext>5 GTT, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL VALERATE/DIENOGEST</medicinalproduct>
        <drugauthorizationnumb>022252</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECONGEX PLUS</medicinalproduct>
        <drugdosagetext>1 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHINITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564471-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC-E2020-11139-SPO-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>020690</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564472-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-JNJFOC-20120613141</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOCOID</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>17450</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPROSALIC</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564473-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714553</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564474-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120715101</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564475-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugauthorizationnumb>021346</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COGENTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>AKATHISIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564476-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2012SA054056</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564478-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>141</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-TESTOSTERONE</medicinalproduct>
        <drugauthorizationnumb>085635</drugauthorizationnumb>
        <drugdosagetext>UNK, WEEKLY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564479-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugauthorizationnumb>19430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564480-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012186386</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEREPRILE</medicinalproduct>
        <drugdosagetext>2 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SENILE PSYCHOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFAXIMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>0.25 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KONAKION</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564481-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564482-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012188197</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564483-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010138654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL STATUS CHANGES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 UNITS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>9.6 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENTAL STATUS CHANGES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>400 MCG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>600 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAPINEUZUMAB</medicinalproduct>
        <drugdosagetext>0.5 MG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100726</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, TID AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEDATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>AGITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101023</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG DAILLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAPINEUZUMAB</medicinalproduct>
        <drugdosagetext>0.5 MG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100426</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100610</drugenddate>
        <drugtreatmentduration>130</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>RESTLESSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM</medicinalproduct>
        <drugdosagetext>30 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564484-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564485-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012186374</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564486-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012185198</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>113</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPEN WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>225 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMIZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564487-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2012185105</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564488-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012185795</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564489-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186215</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POLYARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564490-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012188207</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564491-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE ANALYSIS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugbatchnumb>1271110</drugbatchnumb>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT URINARY TRACT NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564492-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012185827</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564493-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012185786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.2 MG/DAY, 7 INJECTIONS/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081212</drugenddate>
        <drugtreatmentduration>765</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564494-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564495-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186156</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>3 MG</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564496-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012186301</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID INTAKE REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MOXONIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPIVERINE</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY INCONTINENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>3.5 MG/5ML</drugdosagetext>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>19787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564497-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012184626</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564498-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012185555</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESMOPRESSIN ACETATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD ANTIDIURETIC HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE PHENYL PROPIONATE INJ</medicinalproduct>
        <drugindication>BLOOD FOLLICLE STIMULATING HORMONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.6 MG/DAY, 7 INJECTIONS/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ADRENAL INSUFFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE PHENYL PROPIONATE INJ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD LUTEINISING HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564499-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2012185039</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>0.125 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULATARD NPH HUMAN</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>1 DF, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AROMASIN</medicinalproduct>
        <drugauthorizationnumb>020753</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564500-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012185849</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564501-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E7389-02770-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>119</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564502-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022425</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564503-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-SANOFI-AVENTIS-2011SA081427</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THALASSAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE:2 UNIT(S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugdosagetext>DOSE:2 UNIT(S)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111108</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564504-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16794232</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERBITUX</medicinalproduct>
        <drugdosagetext>MOST RECENT DOSE ON 04APR12  INTERRUPTED  RESUMED ON 11JUL12, RECENT INF 25JUL12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564505-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20110911019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSESSIVE-COMPULSIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM MULTI-SYMPTOM RELIEF</medicinalproduct>
        <drugbatchnumb>BJF013;CHF038</drugbatchnumb>
        <drugauthorizationnumb>021140</drugauthorizationnumb>
        <drugdosagetext>1 CAPLET DAILY IN THE MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUVOXAMINE MALEATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CREAMS NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SKIN IRRITATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMODIUM MULTI-SYMPTOM RELIEF</medicinalproduct>
        <drugbatchnumb>BJF013;CHF038</drugbatchnumb>
        <drugauthorizationnumb>021140</drugauthorizationnumb>
        <drugdosagetext>1 CAPLET DAILY IN THE MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564506-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711986</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>2 CAPLETS EVERY 4-6 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED SLEEPING AGENTS</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564507-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800293</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIODONTAL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROIDS NOS</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564508-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800435</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564509-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20111203973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>5 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564510-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20111006851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTLINE HYDROCHLORIDE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564511-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20111207330</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564512-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16802142</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEPANTHENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564513-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16742637</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMEND</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>NO OF COURSES 8</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>NO OF COURSES 4</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>NO OF COURSES 12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564514-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2011SE27524</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564515-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-16577231</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>607680</drugbatchnumb>
        <drugdosagetext>RECENT DOSE: APR12</drugdosagetext>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>607681</drugbatchnumb>
        <drugdosagetext>RECENT DOSE: APR12</drugdosagetext>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>607682</drugbatchnumb>
        <drugdosagetext>RECENT DOSE: APR12</drugdosagetext>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>642467</drugbatchnumb>
        <drugdosagetext>RECENT DOSE:APR12</drugdosagetext>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564516-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000417</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIOPTAN</medicinalproduct>
        <drugauthorizationnumb>202514</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564517-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1107USA01259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHIC VULVOVAGINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNS SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERMAL BURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080530</drugenddate>
        <drugtreatmentduration>4745</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>37.5/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020916</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>2907</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011008</drugenddate>
        <drugtreatmentduration>2190</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, QM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 MARINE TRIGLYCERIDES</medicinalproduct>
        <drugdosagetext>100-1000 IU</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLECALCIFEROL</medicinalproduct>
        <drugdosagetext>400-1000 IU</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20-40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564518-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA029640</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY: EVERY 4 WEEKS.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUPROLIDE ACETATE</medicinalproduct>
        <drugdosagetext>3.75 MG/24H EVERY FOUR WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE, 6.6 MG/DAYEVERY ADMINISTRATION OF TAXOTERE</drugdosagetext>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>EVERY ADMINISTRATION OF TAXOTERE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACYT</medicinalproduct>
        <drugdosagetext>STRENGTH: 156.7 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564519-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16823940</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOMBIGLYZE XR</medicinalproduct>
        <drugauthorizationnumb>200678</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564520-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16802720</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KOMBIGLYZE XR</medicinalproduct>
        <drugauthorizationnumb>200678</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564521-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16817850</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564522-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16835415</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564523-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16220782</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PARAPLATIN AQ</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugauthorizationnumb>020262</drugauthorizationnumb>
        <drugdosagetext>ROUTE :IV</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OVARIAN CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564524-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-16784761</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugbatchnumb>607852</drugbatchnumb>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>607851</drugbatchnumb>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>607580</drugbatchnumb>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>607853</drugbatchnumb>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564525-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16809253</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugbatchnumb>1W6013D</drugbatchnumb>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564526-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-BRISTOL-MYERS SQUIBB COMPANY-16812141</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>DOSE INCREASED TO 30 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564527-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16677460</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINEPHRINE</medicinalproduct>
        <drugdosagetext>1:1000</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANAPHYLACTIC REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564528-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-EISAI INC-E7389-02775-SOL-PH</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564529-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20120713366</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE ANALGESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>088790</drugauthorizationnumb>
        <drugdosagetext>EXPRESSED AS MEDIAN, IN MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>EXPRESSED AS MEDICAN IN MG/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HCL</medicinalproduct>
        <drugauthorizationnumb>21217</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>EXPRESSED AS MEDIAN IN MG/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugdosagetext>EXPRESSED AS MEDIAN, IN MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564530-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-JNJFOC-20120714973</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN</medicinalproduct>
        <drugauthorizationnumb>21123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMINOGLYCOSIDE ANTIBACTERIALS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATAZANAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTEASE INHIBITORS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTI-PSYCHOTICS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPYL-THIOURACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>020505</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERBAL MEDICINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEPHALOSPORINS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN AND CLAVULANATE POTASSIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564531-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120800524</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>CUMMULATIVE DOSE UNTIL SEP-2011 WAS 200 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOCILIZUMAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLIMUMAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564532-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120704469</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>28 CAPSULES, 4 TIMES A DAY FOR 7 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>28 CAPSULES, 4 TIMES A DAY FOR 7 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugbatchnumb>CDL0N00</drugbatchnumb>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAKTACORT</medicinalproduct>
        <drugauthorizationnumb>017450</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugauthorizationnumb>020083</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>28 CAPSULES, 4 TIMES A DAY FOR 7 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCLOXACILLIN</medicinalproduct>
        <drugdosagetext>28 CAPSULES, 4 TIMES A DAY FOR 7 DAYS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CELLULITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICONAZOLE</medicinalproduct>
        <drugbatchnumb>CDL0N00</drugbatchnumb>
        <drugauthorizationnumb>17450</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564533-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120412731</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE INTENTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIC-ISCHAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564534-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564535-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012179767</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>115</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>150 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIDO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>15 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPOPITUITARISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564536-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1010USA03509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BONE DENSITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080705</drugenddate>
        <drugtreatmentduration>6257</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564537-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1207FRA010028</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>6000 IU, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOCEPREVIR</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>20000 IU, QW</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUPHALAC</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>150 MICROGRAM, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>50 MG, UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564538-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19830524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-83060034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012704</drugauthorizationnumb>
        <drugdosagetext>50 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830428</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564539-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564540-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP020573</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>FORMULATION POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>1800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugdosagetext>FORMULATION POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564541-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-AP-00617AP</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientweight>6.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATROVENT</medicinalproduct>
        <drugbatchnumb>CA 105250</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564542-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-RD-00231EU</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS MICROSCOPIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>32 MU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>28 MU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BI 1356</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIAL PROCEDURE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>ATHEROSCLEROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCAL</medicinalproduct>
        <drugindication>ATHEROSCLEROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOORAMPENICOL</medicinalproduct>
        <drugindication>MACULAR OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>32 MU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>38 MU</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564543-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-13845NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REFLUX GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>0.125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564546-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0954910-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLATE DE LYSINE</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URTICARIA CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564547-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19860402</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-86040132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012704</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19841001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19860101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564548-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012594</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POSTERISAN</medicinalproduct>
        <drugdosagetext>Q.S.</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ANORECTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOBU</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564549-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010911</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugbatchnumb>1C62002</drugbatchnumb>
        <drugdosagetext>120 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564550-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000559</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIMOPTIC IN OCUDOSE</medicinalproduct>
        <drugauthorizationnumb>018086</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564551-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012593</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120317</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.204 MICROGRAM/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFENAMIC ACID</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120514</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLAL</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.024 MICROGRAM/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564552-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-009507513-1207DNK005115</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUMETIN</medicinalproduct>
        <drugdosagetext>STYRKE: 600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>STYRKE: 750 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXONIDIN ACTAVIS</medicinalproduct>
        <drugdosagetext>STYRKE: 0,2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>STYRKE: 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>STYRKE: 750 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>STYRKE: 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>STYRKE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOL ORIFARM</medicinalproduct>
        <drugdosagetext>STYRKE: 30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUMETIN</medicinalproduct>
        <drugdosagetext>STYRKE: 600 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>STYRKE: 100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>STYRKE: 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>STYRKE: 5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>STYRKE: 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564553-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19850128</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-85010321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012704</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORIDEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564558-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-349139USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564559-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120710461</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564560-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20120714675</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564561-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800481</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080506</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION (UNKNOWN)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564562-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120600840</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugdosagetext>3MG IN MORNING 3MG IN AFTERNOON AND 3MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugdosagetext>3MG IN MORNING,1MG IN AFTERNOON,3MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugdosagetext>3MG IN MORNING,1MG IN AFTERNOON,3MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugdosagetext>3MG IN MORNING 3MG IN AFTERNOON AND 3MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugdosagetext>3MG IN MORNING 3MG IN AFTERNOON AND 3MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>BFB6C00</drugbatchnumb>
        <drugauthorizationnumb>020588</drugauthorizationnumb>
        <drugdosagetext>3MG IN MORNING,1MG IN AFTERNOON,3MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564563-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012186675</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAESAREAN SECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564564-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012186924</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564565-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187363</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564566-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012188094</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564567-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187034</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564568-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012188121</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564569-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>C10015830</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120802</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG, AS NEEDED</drugdosagetext>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564570-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187740</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.807</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATIENT-DEVICE INCOMPATIBILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564571-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187575</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPEN ANGLE GLAUCOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564572-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564573-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012185479</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>050608</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>MONONUCLEOSIS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNASYN</medicinalproduct>
        <drugauthorizationnumb>050608</drugauthorizationnumb>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564574-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186923</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugauthorizationnumb>011459</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564575-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012183250</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564576-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188204</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.365</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564577-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012186663</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SCLERODERMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVIX CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564578-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187343</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564579-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186865</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.515</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TABLET PHYSICAL ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>PANIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>1MG FOUR TIMES A DAY AND 2MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564580-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPRANOLOL HCL</medicinalproduct>
        <drugauthorizationnumb>016418</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564581-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TN-PFIZER INC-2012187968</companynumb>
    <primarysource>
      <reportercountry>TUNISIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564582-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012187366</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>25 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564583-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-SANOFI-AVENTIS-2012SA053803</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC MUCOSAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>2393</drugbatchnumb>
        <drugauthorizationnumb>020839</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090507</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020507</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564589-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077286</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564590-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075632</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564591-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BAYER-2012-075795</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.819</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERETIDE MDI</medicinalproduct>
        <drugdosagetext>1-4 PUFFS/DAY</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>2.5-5 MG PRN</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PORTAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
        <drugdosagetext>34 U, UNK</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>30-60ML</drugdosagetext>
        <drugindication>HEPATIC ENCEPHALOPATHY PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THIAMINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN HCL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINORUM</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM ASPARTATE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110918</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564592-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E7389-02117-CLI-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHANGIOSIS CARCINOMATOSA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO LYMPH NODES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>METASTASES TO BREAST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111021</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MARZULENE-S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLEURAL EFFUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111221</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO CHEST WALL</drugindication>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDONINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564593-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-12040288</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564594-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564595-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010023114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.19</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564596-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012180234</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RICKETS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>1.1 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TURNER'S SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564597-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564598-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012173862</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPARA-CA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564599-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-PFIZER INC-2012182338</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TERRA-CORTRIL POLYMYXIN B</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564600-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564601-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012179664</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>6000 MG, TOTAL DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF INJURIOUS BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, TOTAL DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF INJURIOUS BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugauthorizationnumb>18276</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, TOTAL DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SELF INJURIOUS BEHAVIOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564602-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012185492</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATGAM</medicinalproduct>
        <drugdosagetext>2160 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>30 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA HAEMOLYTIC AUTOIMMUNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564603-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012177487</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564604-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12021975</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENGRAFTMENT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugdosagetext>75 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111216</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120102</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564605-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012182981</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HYCLATE</medicinalproduct>
        <drugauthorizationnumb>50007</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MALARIA PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564606-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-12072606</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564607-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012181495</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>47</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugauthorizationnumb>050684</drugauthorizationnumb>
        <drugdosagetext>4.5 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564608-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012184107</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK COMPLETE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugauthorizationnumb>018972</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>365</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564609-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-PFIZER INC-2012178219</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL VARICES HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXTROMETHORPHAN</medicinalproduct>
        <drugindication>INTERSTITIAL LUNG DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564610-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012183552</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>1ST COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>1ST COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>3RD COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>1ST COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2ND COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>2ND COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>3RD COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>3RD COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLINIC ACID</medicinalproduct>
        <drugdosagetext>2ND COURSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564611-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188206</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY, TAKE 1 CAPSULE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugindication>METASTASES TO ADRENALS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>078244</drugauthorizationnumb>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564612-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012182422</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG IN THE MORNING AND 400 MG IN THE BEDTIME</drugdosagetext>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>500 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564613-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012183020</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOLTERODINE TARTRATE</medicinalproduct>
        <drugauthorizationnumb>021228</drugauthorizationnumb>
        <drugdosagetext>4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTONIC BLADDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564614-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012178060</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>50778</drugauthorizationnumb>
        <drugdosagetext>108.75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>725 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>725 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL CITRATE</medicinalproduct>
        <drugdosagetext>12 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>30 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETALAR</medicinalproduct>
        <drugdosagetext>4 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>400 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANCER PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SITAGLIPTIN PHOSPHATE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564615-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012184074</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564616-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012182839</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
        <drugdosagetext>12 GTT, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>171</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL HEMIFUMARATE/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROFOLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugauthorizationnumb>019999</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>536</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564617-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19820621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-82070162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLINASE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugdosagetext>600 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19820614</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564618-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA02887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>4015</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564619-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012600</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5G/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120528</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.8G/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564620-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110218</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-2009SP000009</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED PRE TRIAL THERAPY</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAFERONPEG</medicinalproduct>
        <drugdosagetext>45 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED POST TRIAL THERAPY</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED PRE TRIAL THERAPY</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED POST TRIAL THERAPY</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED POST TRIAL THERAPY</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED PRE TRIAL THERAPY</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>INITIATED PRIOR STUDY</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081219</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564621-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054169</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>89.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020449</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DOSE/FREQUENCY- 15 MG/KG OVER 30-90 MIN ON DAY 1 OF A CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>PATINET TOOK EVERY 4 HOURS BY MISTAKE</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20449</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY- 75 MG/M2 OVER 60 MIN ON DAY 1 OF A CYCLEDOCETAXEL WAS HELD FOR CUMULATIVE TOXICITIES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564624-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-UCBSA-059472</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564625-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRACT2012001123</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>F85250</drugbatchnumb>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, ONCE WEEKLY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564626-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-CELGENEUS-286-21880-12072600</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564630-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-12063743</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WHOLE BLOOD</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564631-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E2090-02239-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AKINESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugdosagetext>300 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564632-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-UCBSA-062799</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
        <drugtreatmentduration>17</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREGABALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DOSE:75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564633-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19870311</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-87030522</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECALOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012704</drugauthorizationnumb>
        <drugdosagetext>2125 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPROMAZINE HCL</medicinalproduct>
        <drugdosagetext>2500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OVERDOSE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564635-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1208JPN000049</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STATUS EPILEPTICUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugauthorizationnumb>012703</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564636-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA01126</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050119</drugstartdate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK MG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061002</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080306</drugenddate>
        <drugtreatmentduration>522</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100706</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERAPY UNSPECIFIED</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100425</drugenddate>
        <drugtreatmentduration>320</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK MG, QW</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101014</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101229</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK MG, QW</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110210</drugenddate>
        <drugtreatmentduration>5899</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060721</drugenddate>
        <drugtreatmentduration>156</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>UNK UNK, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080604</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564637-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16976BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564638-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-15060BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>259321A</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugbatchnumb>259321A</drugbatchnumb>
        <drugauthorizationnumb>021162</drugauthorizationnumb>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564639-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2011-BP-03032BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>125 MCG</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>120 MG</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564640-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-15161BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IRON DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>ABDOMINAL ADHESIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>22512</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>BLOOD IRON DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564641-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17034BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>0.2 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>1728000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugdosagetext>400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>320 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564643-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16693BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564644-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17165BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>106078</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564645-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16689BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>159573A</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564648-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713086</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564649-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120800492</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALIGNANT ANORECTAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564650-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711675</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564651-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120710211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564652-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120205614</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564653-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYTIGA</medicinalproduct>
        <drugauthorizationnumb>202379</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564654-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA012439</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENZACLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050756</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564655-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100708</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564656-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014939</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>075876</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080711</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPINAL OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090206</drugenddate>
        <drugtreatmentduration>716</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564657-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-EISAI INC-E7389-01327-CLI-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENSIMATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564658-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19821025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-82110001</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIRSUTISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19801101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564659-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MSD-1203USA03294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALABSORPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUBIS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPASE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ULNA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADENOIDAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
        <drugtreatmentduration>2434</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9359</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70-2800</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011213</drugenddate>
        <drugtreatmentduration>547</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564660-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1109USA02130</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MERALGIA PARAESTHETICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON ADENOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FIBROCYSTIC BREAST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091125</drugenddate>
        <drugtreatmentduration>500</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100115</drugenddate>
        <drugtreatmentduration>4398</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>40 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITA C</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugtreatmentduration>7300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>7300</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>35 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050613</drugenddate>
        <drugtreatmentduration>163</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564661-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959249-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIALDA</medicinalproduct>
        <drugdosagetext>4 PILLS IN AM</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
        <drugdosagetext>37.5 MG DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564662-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-ABBOTT-12P-131-0936130-00</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DERMATOMYOSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>75/25, 15U IN MORNING, 7U AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564663-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959969-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABORTION SPONTANEOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLIGHTED OVUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 TABS/CAPS DAILY, COURSE #1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>4 TABS/CAPS DAILY; COURSE #1</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564665-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAXTER-2012BAX012851</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VON WILLEBRAND FACTOR_650 IU/VIAL_POWDER FOR SOLUTION FOR INFUSION_VIA</medicinalproduct>
        <drugbatchnumb>TVA11002AA, LE01L507AT,TVA11002AA,</drugbatchnumb>
        <drugdosagetext>TOTAL VOLUME INFUSED 51.0 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VON WILLEBRAND FACTOR_650 IU/VIAL_POWDER FOR SOLUTION FOR INFUSION_VIA</medicinalproduct>
        <drugbatchnumb>TVA11002AA, LE01L507AT,TVA11002AA,</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VON WILLEBRAND FACTOR_650 IU/VIAL_POWDER FOR SOLUTION FOR INFUSION_VIA</medicinalproduct>
        <drugbatchnumb>TVA11002AA, LE01L507AT,TVA11002AA,</drugbatchnumb>
        <drugdosagetext>6.0 ML TOTAL VOLUME INFUSED</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VON WILLEBRAND FACTOR_650 IU/VIAL_POWDER FOR SOLUTION FOR INFUSION_VIA</medicinalproduct>
        <drugbatchnumb>TVA11002AA, LE01L507AT,TVA11002AA,</drugbatchnumb>
        <drugdosagetext>TOTAL VOLUME INFUSED 51.0 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VON WILLEBRAND FACTOR_650 IU/VIAL_POWDER FOR SOLUTION FOR INFUSION_VIA</medicinalproduct>
        <drugbatchnumb>TVA11002AA</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>VON WILLEBRAND'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VON WILLEBRAND FACTOR_650 IU/VIAL_POWDER FOR SOLUTION FOR INFUSION_VIA</medicinalproduct>
        <drugbatchnumb>TVA11002AA, LE01L507AT,TVA11002AA,</drugbatchnumb>
        <drugdosagetext>TOTAL VOLUME INFUSED 51.0 ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564666-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564667-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-MYLANLABS-2012S1014947</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>090335</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT:1500 UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>090335</drugauthorizationnumb>
        <drugdosagetext>DOSE UNIT:300 UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>MOOD ALTERED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564668-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugdosagetext>ADDED 25UG/HR AS NEEDED AS PRESCRIBED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>3 VIALS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564669-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564670-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120314809</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564672-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715098</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564673-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12032703</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110928</drugenddate>
        <drugtreatmentduration>843</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOGRASTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERREM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOGRASTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGOCID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
        <drugtreatmentduration>843</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DISEASE PROGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYGACIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUSOPT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564674-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MYLANLABS-2012S1015052</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugauthorizationnumb>72741</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>DABIGATRAN ETEXILATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564675-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-009507513-1208ROM000193</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564676-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP024672</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION (BEPOTASTINE BESYLATE)</medicinalproduct>
        <drugdosagetext>TRADE NAME: TALION OD, CUMULATIVE DOSE: 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120219</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINO ACIDS (UNSPECIFIED) (+) DEXTROSE</medicinalproduct>
        <drugdosagetext>500 ML, QD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100MCG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
        <drugtreatmentduration>48</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80MCG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>100MCG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>2.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION (BEPOTASTINE BESYLATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120219</drugenddate>
        <drugtreatmentduration>46</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564677-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19840410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-82110239</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19810722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19810914</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564678-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-MYLANLABS-2012S1015055</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ALKALOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugauthorizationnumb>018487</drugauthorizationnumb>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564679-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VERTEX PHARMACEUTICALS INC.-AE-2011-000335</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIASCLEDINE</medicinalproduct>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIPTOL</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESLORATADINE</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VX-950</medicinalproduct>
        <drugauthorizationnumb>71832</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564680-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-VERTEX PHARMACEUTICALS INC.-000000000000001288</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564681-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOCIAL AVOIDANT BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUROPHET</medicinalproduct>
        <drugdosagetext>20MG AT 8AM, 12PM AND 5PM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COMPLEX PARTIAL SEIZURES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugauthorizationnumb>076314</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1000MG AT BEDTIME</drugdosagetext>
        <drugindication>INTERMITTENT EXPLOSIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>0.1MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564685-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207003052</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564686-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201201008762</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>XEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTONE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>960 MG, EVERY THREE WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>0.4 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLOPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564687-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207007818</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564688-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564689-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201208000137</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564690-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201208000139</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564691-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201206009633</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRERENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHIC ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>4 IU, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARGIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALCID</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>12 IU, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>12 IU, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>FF6H48D</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>12 IU, EACH MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>9 IU, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564692-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201205008708</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>2000 MI, OVER 24H</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIVALIRUDIN</medicinalproduct>
        <drugdosagetext>5 MG/ML, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120421</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120421</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL HEXAL</medicinalproduct>
        <drugdosagetext>1.25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN RATIOPHARM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>60 MG, SINGLE LOADING DOSE</drugdosagetext>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564693-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207008243</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA STAGE IV</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564694-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564695-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008932</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS IN DEVICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugauthorizationnumb>022307</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564696-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008372</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>0.15 U, QD</drugdosagetext>
        <drugindication>THYROIDITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564697-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201203004786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.841</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PITUITARY TUMOUR RECURRENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMATROPE</medicinalproduct>
        <drugbatchnumb>A863304A</drugbatchnumb>
        <drugauthorizationnumb>019640</drugauthorizationnumb>
        <drugdosagetext>0.4 MG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HYPOTHALAMO-PITUITARY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564698-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201203002033</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINE PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASCON</medicinalproduct>
        <drugdosagetext>120 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>700 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101214</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>1000 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 UG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>700 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARGE CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>100 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LARGE CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
        <drugtreatmentduration>86</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>1 G, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugauthorizationnumb>021462</drugauthorizationnumb>
        <drugdosagetext>700 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugdosagetext>35 MG/M2, UNK</drugdosagetext>
        <drugindication>LARGE CELL LUNG CANCER STAGE III</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
        <drugtreatmentduration>82</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101231</drugenddate>
        <drugtreatmentduration>173</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564699-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>2836</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>2836</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564700-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012603</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150MCG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564701-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012606</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PYELONEPHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOBAN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.9MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEBURIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564702-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-MYLANLABS-2012S1015212</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>078224</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564703-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-CELGENEUS-008-50794-12072853</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564704-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BAYER-2012-057210</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugbatchnumb>13782E</drugbatchnumb>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>6 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120104</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564705-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-JNJFOC-20120801437</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANTINUCLEAR ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>0,2,6,14 AND 22 (32) WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564706-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2011012573</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPTIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564707-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>KR-MYLANLABS-2012S1015212</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PEMPHIGOID</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugauthorizationnumb>076418</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564708-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120712686</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110328</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564709-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA000440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>HMLX90</drugbatchnumb>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564710-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP036778</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564711-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19830308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-83030158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19811201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19820120</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugdosagetext>300 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19810620</drugenddate>
        <drugtreatmentduration>385</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19730401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564712-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA001225</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564713-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-061661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>INDUCTION DOSE</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564714-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012048266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070728</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564715-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0950558-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE DRUG REACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>6MG/WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564716-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956801-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564717-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ABBOTT-12P-013-0927586-03</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564718-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961367-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EROSIVE OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARGE INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>LOADING DOSE ONLY</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564719-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958621-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESAVISION</medicinalproduct>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRESAVISION</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW RELEASE IRON</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE/CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIAL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>140822E</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564720-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ABBOTT-12P-087-0962710-00</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABORTION INDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE + ZIDOVUDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564721-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2012SA053147</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>19.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MONOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugdosagetext>DOSE: 10 MG/KG/DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAFORAN</medicinalproduct>
        <drugbatchnumb>B2N882</drugbatchnumb>
        <drugauthorizationnumb>050547</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564722-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1204USA01368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CALCIUM DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090928</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugbatchnumb>U5259</drugbatchnumb>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>4422</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100920</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110727</drugenddate>
        <drugtreatmentduration>311</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564724-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351649USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564725-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>MAINTENANCE</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564726-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564727-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-070899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564728-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-041562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564729-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-068953</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>54024GR</drugbatchnumb>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564730-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PURULENT DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564731-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-065584</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>40</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOSARCOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMATOSIS INTESTINALIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOMA OF SKIN</drugindication>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564735-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA052041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugbatchnumb>CH39F</drugbatchnumb>
        <drugauthorizationnumb>020872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564736-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA001059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PELVIC INFLAMMATORY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564737-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-MX-00071MX</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINO</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN ETEXILATE</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>450 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120213</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugauthorizationnumb>21162</drugauthorizationnumb>
        <drugdosagetext>STRENGTH: 80/12.5MG DAILY DOSE: 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DABEX</medicinalproduct>
        <drugdosagetext>850 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN ETEXILATE</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564738-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564739-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugdosagetext>100 MG, 1 BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, 1 MORNING-1NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>50 MG, 1 MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>600 MG, 1 NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, 1 NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, 2 MORNING, 2 NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1 MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>80 MG, 1 MORNING-1NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, 2 MORNING, 2 NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>300 MG, 1 MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG, MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>10 UNIT, HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, 1 MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50 MG, 1 MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1 NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564740-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-SANOFI-AVENTIS-2012SA054390</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HCL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020872</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564741-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2012SA036097</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORGANISING PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>12 CYCLES</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>12 CYCLES</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>12 CYCLES</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564742-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564743-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-12070706</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564744-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2011S1004247</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66.68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564748-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTELLAS-2012JP006620</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110211</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TPN                                /00897001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110224</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RINDERON                           /00008502/</medicinalproduct>
        <drugdosagetext>0.5 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEREKINON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101221</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTRIL                            /00028601/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>50708</drugauthorizationnumb>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>483</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOFERMIN                          /01617201/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERRUM                             /00023505/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110209</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugauthorizationnumb>050708</drugauthorizationnumb>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110215</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>3000 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564749-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMNESTEEM</medicinalproduct>
        <drugauthorizationnumb>075945</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564750-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>075986</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564751-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-1205USA01891</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COAGULATION FACTOR V LEVEL DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTI FACTOR V ANTIBODY POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEBSIELLA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CITROBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ALVEOLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIENAM IV</medicinalproduct>
        <drugauthorizationnumb>50587</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACHOSIL</medicinalproduct>
        <drugdosagetext>3 UNK, UNK</drugdosagetext>
        <drugindication>HAEMORRHAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120219</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAZOBACTAM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120308</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFOTAXIME SODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564752-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000687</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564753-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOCAL SEGMENTAL GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564754-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-069990</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVITRA</medicinalproduct>
        <drugbatchnumb>54024GR</drugbatchnumb>
        <drugauthorizationnumb>021400</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564755-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564756-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSMENORRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564757-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2012SA054029</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugbatchnumb>131042</drugbatchnumb>
        <drugauthorizationnumb>020786</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564758-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564759-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2012SA053071</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>009768</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564760-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062816</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>APPROXIMATELY ONE YEAR</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564761-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564762-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076129</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564763-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564764-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075980</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00F5Z</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564765-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077589</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00D8L</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564766-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564767-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-075608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564768-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076451</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00890</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564769-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG, ONE TIME PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120222</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, BID AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>600 MG, EVERY 6 HOURS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5-325MG, Q4HR, 1TO 2 TABS AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564770-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-051350</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120203</drugenddate>
        <drugtreatmentduration>387</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564771-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRACRANIAL VENOUS SINUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCOSAHEXANOIC ACID/EICOSAPENTAENOIC ACID</medicinalproduct>
        <drugdosagetext>1200 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100416</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>60 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D3 [CALCIUM CARBONATE,COLECALCIFEROL]</medicinalproduct>
        <drugdosagetext>1250/200 UNIT TABLET, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUATION IRREGULAR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091023</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugindication>HORMONE LEVEL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>7.5 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, HS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564773-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2012SA051341</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
        <drugindication>ADJUVANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564774-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TW-CELGENEUS-153-20785-12070378</companynumb>
    <primarysource>
      <reportercountry>TAIWAN, PROVINCE OF CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EMBOLISM VENOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugdosagetext>40 -480 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugdosagetext>50 -400</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NTERFERON ALFA</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564775-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-11122237</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS B</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111211</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111209</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111211</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111207</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAMIDRONATE DISODIUM</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111208</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111130</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564776-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2012SA051341</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
        <drugindication>ADJUVANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021759</drugauthorizationnumb>
        <drugdosagetext>ROUTE: INFUSION</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564777-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-SANOFI-AVENTIS-2012SA053683</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS TOXIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020905</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564778-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-CELGENEUS-251-21880-12070412</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPTRAL</medicinalproduct>
        <drugdosagetext>800 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>HEPATITIS TOXIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111002</drugenddate>
        <drugtreatmentduration>40</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIM</medicinalproduct>
        <drugdosagetext>4000 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110911</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>304</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETON</medicinalproduct>
        <drugdosagetext>90 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EGILOK</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTROPID</medicinalproduct>
        <drugdosagetext>10 IU (INTERNATIONAL UNIT)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111003</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564780-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7028464</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564781-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7043502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110202</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564782-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7151152</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugdosagetext>FOR ONE TO TWO YEARS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564783-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7050873</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564784-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7146683</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COAGULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021010</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564785-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7148565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SELF-INJURIOUS IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>223</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564786-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7052361</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564787-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ANTIDEPRESSANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003024</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDOL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564788-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564789-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150960</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564790-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7103729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090323</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564791-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7148905</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10/325</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>MICTURITION URGENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002604</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564792-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7052680</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564793-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564795-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351380USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONIC CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>075977</drugauthorizationnumb>
        <drugdosagetext>TOOK 84 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULOXETINE</medicinalproduct>
        <drugdosagetext>60MG DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>075977</drugauthorizationnumb>
        <drugdosagetext>50MG AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564796-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-AMGEN-FRANI2012042392</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>135 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>680 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>680 MG, Q2WK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TETRALYSAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugbatchnumb>1031063</drugbatchnumb>
        <drugdosagetext>100 MG, Q2WK</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564797-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-SANOFI-AVENTIS-2011SA085111</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111124</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050420</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111124</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PYRAZINAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111124</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111124</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564798-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351469USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugauthorizationnumb>070152</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTETRO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564799-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0959726-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA CONGENITAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564800-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0961517-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFANTILE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020945</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564801-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-ABBOTT-12P-131-0953307-00</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCCULT BLOOD POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>8MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564802-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078424</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GADAVIST</medicinalproduct>
        <drugbatchnumb>21273C</drugbatchnumb>
        <drugauthorizationnumb>201277</drugauthorizationnumb>
        <drugdosagetext>6 ML, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564803-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-255074USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNINTENDED PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARAVIS</medicinalproduct>
        <drugauthorizationnumb>076135</drugauthorizationnumb>
        <drugdosagetext>80 MILLIGRAM;</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101029</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564804-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351568USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564805-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-SANOFI-AVENTIS-2012SA053399</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOCLASTIC VASCULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIFADIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>050420</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERITONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERITONITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564807-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012129268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564808-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351832USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564809-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008652</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FIBULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>2104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>2104</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564810-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP010634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100324</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564811-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-009507513-2012SP033871</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, TID</drugdosagetext>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>TYPE V HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCARNIL</medicinalproduct>
        <drugdosagetext>100 MG, TID</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOCEPREVIR</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>2400 MG, QD</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>245 MG, QOD</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>80 MICROGRAM, QW</drugdosagetext>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORECORMON</medicinalproduct>
        <drugdosagetext>30000 IU, QW</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REYATAZ</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>0.4 MG, QD</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugindication>INFLUENZA LIKE ILLNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
        <drugindication>ANGER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXERYL TABLETS</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>DRY SKIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564812-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA001114</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE ACETATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZASITE</medicinalproduct>
        <drugbatchnumb>IN11F12A</drugbatchnumb>
        <drugauthorizationnumb>050810</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>CATARACT OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZELAPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564813-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19840612</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-84060132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELDENE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLINORIL</medicinalproduct>
        <drugauthorizationnumb>017911</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19830801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564814-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-050504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>DOSE:200 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
        <drugtreatmentduration>207</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>DOSE:400 MG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110627</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564815-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12071259</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564816-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50791</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>160/4.5, TWO PUFFS BID</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564817-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-VERTEX PHARMACEUTICALS INC.-000000000000001287</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564818-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073257</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564819-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12050345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>.0333 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564820-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-AB007-11112572</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>021660</drugauthorizationnumb>
        <drugdosagetext>125 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>ADENOCARCINOMA PANCREAS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>125 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564821-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008636</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120204</drugenddate>
        <drugtreatmentduration>383</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564822-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201204006997</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANEURYSM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDACATEROL</medicinalproduct>
        <drugdosagetext>1 DF, QOD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMURO DE IPRATROPIO</medicinalproduct>
        <drugdosagetext>20 CGR, QOD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A927668E</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 DF, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>18 H, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564823-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207004887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A939725C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                                 /SCH/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A939725G</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564824-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008642</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564825-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201104003410</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A719438C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A897246J</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564826-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201206001050</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL AVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM BICARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URALYT U                           /01675401/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564827-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008487</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564828-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564829-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201204000496</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564830-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207007384</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564831-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201201000170</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT FLUID DRAINAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A862854C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564832-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ELI_LILLY_AND_COMPANY-FI201203002022</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISCERAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN                             /00084401/</medicinalproduct>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMASPAN</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUREKAL</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OBSIDAN                            /00023514/</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110103</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564833-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201206004427</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>265</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE                           /00944201/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564834-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201207009010</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ARTHRITIS</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564835-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201207008667</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564836-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201202000400</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT BEARING DIFFICULTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STERNAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120128</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>166</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTROLYTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564837-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008695</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564838-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201103002768</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>UNK, OTHER</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A888230C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>1 G, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMAN INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A738557C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A817047D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRENTAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564839-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008668</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564840-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008774</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564841-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugdosagetext>125 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564842-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207007844</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564843-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-ELI_LILLY_AND_COMPANY-MX201207008910</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564844-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207003024</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564845-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201208000335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENOUS STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020815</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564846-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201102001867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR OF FALLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPIRED DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A883536C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A860864G</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A875668C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A536344C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A888230C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROINTESTINAL TRACT IRRITATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, DAILY (1/D)</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564847-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207007846</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564848-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ELI_LILLY_AND_COMPANY-AU201204007964</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REANDRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTELIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564849-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-ELI_LILLY_AND_COMPANY-ES201207008639</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564850-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201109002369</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>250 UG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A888230C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRICAL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEA, GREEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT AQ</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugdosagetext>10.20 MG, UNKNOWN</drugdosagetext>
        <drugindication>NASAL CONGESTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUTRI-JOINT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugdosagetext>1200 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>100 MG, PRN</drugdosagetext>
        <drugindication>RESPIRATORY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESVERATROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A875282D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-50</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKGO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564851-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201112000660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A860866F</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>306</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>SJOGREN'S SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASALCROM</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>ALLERGY PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A865644C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A875667C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877625C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564852-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564853-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207008278</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564854-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207006928</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564855-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008834</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A883534G</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564856-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-CELGENEUS-044-21880-12073183</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugindication>DISEASE PROGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DISEASE PROGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOMA RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090406</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MYELOMA RECURRENCE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DISEASE PROGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DISEASE PROGRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564857-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIMIDEX</medicinalproduct>
        <drugauthorizationnumb>020541</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564858-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0972669A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564859-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0973029A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REQUIP XL</medicinalproduct>
        <drugauthorizationnumb>022008</drugauthorizationnumb>
        <drugdosagetext>2MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugbatchnumb>1ZP5333</drugbatchnumb>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564860-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0973403A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugbatchnumb>1ZP4983</drugbatchnumb>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564861-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0974366A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120323</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564862-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0976589A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>2TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564863-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0977160A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>400MG PER DAY</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120506</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020658</drugauthorizationnumb>
        <drugdosagetext>3MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564864-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0977516A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564865-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0977698A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564866-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0980362A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564867-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0980469A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564868-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120611</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0980795A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAVAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugbatchnumb>A073465,1ZP5328</drugbatchnumb>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564869-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0981847A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugbatchnumb>1ZP4982,1ZP5328</drugbatchnumb>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564870-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0981967A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STRABISMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBATROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugbatchnumb>1ZP4983B,1ZP49831</drugbatchnumb>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564871-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0982879A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564872-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0982882A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>600MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564873-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0983252A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564874-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0983783A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HORIZANT</medicinalproduct>
        <drugauthorizationnumb>022399</drugauthorizationnumb>
        <drugdosagetext>300MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564875-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA020238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100309</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564876-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351567USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>33802799A</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564877-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-INCYTE CORPORATION-2012IN001390</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INC424</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564878-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-EISAI INC-E7389-02739-CLI-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564879-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50502</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564880-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-EISAI INC-E2090-01974-SPO-ES</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564881-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-022077</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>18</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
        <drugtreatmentduration>228</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564882-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-023913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGESTREL AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
        <drugtreatmentduration>52</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIOXX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZAMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>750 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RETIN-A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN PSE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOXIMETASONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORZOXAZONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DROSPIRENONE AND ETHINYL ESTRADIOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZONATATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>Q-BID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESSALON</medicinalproduct>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDIFIERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZACLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564883-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072826</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564884-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012173761</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564885-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-SANOFI-AVENTIS-2012SA053576</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPRAXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFFLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>80</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BALNEUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYURETHANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564886-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012173742</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564887-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1014441</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugdosagetext>Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>6C0155</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120704</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564888-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16681BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120518</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC ALLERGY PILL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC NASAL SPRAY</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564889-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16657BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020520</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564890-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2011SA083078</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA VERA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPHENE CITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>016131</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564891-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-343268USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENJUVIA</medicinalproduct>
        <drugauthorizationnumb>021443</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564892-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351557USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>33803419A</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564893-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2011SA084772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYCYTHAEMIA VERA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOMIPHENE CITRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>016131</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564894-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959384-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>141502E</drugbatchnumb>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564896-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1012279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugauthorizationnumb>074172</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564897-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1012279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugauthorizationnumb>074172</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564898-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1012279</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>077316</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugauthorizationnumb>077316</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564899-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351587USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MICROGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATHEROSCLEROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugauthorizationnumb>020622</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>150 MICROGRAM;</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564900-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12062845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564901-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015537</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>040326</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564902-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12062787</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>83</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>.4 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VERTIGO</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564903-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-071364</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00E5T</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>MENORRHAGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564904-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077151</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564905-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12070663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>2.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564906-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12080113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564907-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-16809014</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugbatchnumb>142384</drugbatchnumb>
        <drugauthorizationnumb>020758</drugauthorizationnumb>
        <drugdosagetext>1DF: 1 TAB, 300MG + 12.5MG COATED TABS,LONG TIME AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>1 DF: 1 TAB,OSTEONUTRI,ABOUT 1 YEAR AND 3 MONTHS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>1DF: 1 TAB,LONG TIME AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564908-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16674095</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564909-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BRISTOL-MYERS SQUIBB COMPANY-16812422</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERNATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BECLOSPIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG MIX 70/30</medicinalproduct>
        <drugdosagetext>NOVOMIX FLEXPEN 100U/ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>BRONCHOPNEUMONIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564912-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16829335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUSTIVA</medicinalproduct>
        <drugauthorizationnumb>021360</drugauthorizationnumb>
        <drugdosagetext>DOSE REDUCED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIAGEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564913-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16731721</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>THERAPY DATES: 2MAR11,16MAR11</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564914-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564915-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564916-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANORGASMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugbatchnumb>V112125</drugbatchnumb>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564917-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187463</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564918-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012152311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>LIP DRY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC STRAWBERRY</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>LIP DRY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC</medicinalproduct>
        <drugbatchnumb>E14396</drugbatchnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 UG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564919-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187316</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>020246</drugauthorizationnumb>
        <drugdosagetext>UNK, EVERY 3 MONTHS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564920-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-PFIZER INC-2012187476</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERIRENAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>50 MG/DAY FOR 4 WEEKS IN EVERY 6 WEEKS.</drugdosagetext>
        <drugindication>NEUROENDOCRINE CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564921-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS 200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564922-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187178</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.689</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUTENT</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC NEUROENDOCRINE TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564923-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187191</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>25 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120731</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120801</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564924-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.819</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD</medicinalproduct>
        <drugdosagetext>UNK (TWO TEASPOONS), 6X/DAY</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120728</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD</medicinalproduct>
        <drugindication>PHARYNGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD</medicinalproduct>
        <drugindication>INFLUENZA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564925-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564926-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188405</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564927-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186952</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564928-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>HU-BRISTOL-MYERS SQUIBB COMPANY-16228934</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATIC CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED: SAXAGLIPTIN</medicinalproduct>
        <drugauthorizationnumb>22350</drugauthorizationnumb>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
        <drugdosagetext>BEFORE RANDMIZATION-2FEB12,1500MG 3FEB12-CONT, 2000MG</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAPREL</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN INSULIN</medicinalproduct>
        <drugdosagetext>1 DF: 32 UNIT NOS,32IU/U</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564929-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187959</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ERECTION INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564930-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012173266</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564931-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186894</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564932-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182889</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN COUGH AND CHEST CONGESTION DM MAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564933-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012174923</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564934-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187644</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN FALSE POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564936-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187222</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugauthorizationnumb>018422</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564937-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROBITUSSIN LINGERING COLD LONG-ACTING COUGH</medicinalproduct>
        <drugbatchnumb>F79571</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564938-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186812</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>05 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564939-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BRISTOL-MYERS SQUIBB COMPANY-16717928</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugdosagetext>3TABS50MG/D,STARTD MORE THAN 6 MONTHS AGO,INTERRUPTED FOR ABOUT 60 DAYS,RESD WITH 2TABS,1TAB;30D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564940-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012162290</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATGAM</medicinalproduct>
        <drugdosagetext>2400 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>APLASIA PURE RED CELL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANAEMIA HAEMOLYTIC AUTOIMMUNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE MARROW FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564941-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188023</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564942-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564943-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.376</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564944-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564945-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186851</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>8 CONSOLIDATION CYCLES</drugdosagetext>
        <drugindication>MEDULLOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE SULFATE</medicinalproduct>
        <drugdosagetext>WEEKLY, FOLLOWED BY 8 CONSOLIDATION CYCLES</drugdosagetext>
        <drugindication>MEDULLOBLASTOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>91062</drugauthorizationnumb>
        <drugdosagetext>8 CONSOLIDATION CYCLES</drugdosagetext>
        <drugindication>MEDULLOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564946-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187226</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>F91567</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564947-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187415</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564948-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186987</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564949-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187056</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugauthorizationnumb>021393</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564950-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564951-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16662991</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOMA RECURRENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIORBITAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUCERIN CREAM</medicinalproduct>
        <drugdosagetext>CREAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>LAST ADMINISTERED DATE:04MAY2012. REMOVED FROM PROTOCOL ON 08JUN12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564952-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SANOFI-AVENTIS-2012SA054095</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019908</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564953-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1064964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HENOCH-SCHONLEIN PURPURA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMATROPIN RDNA</medicinalproduct>
        <drugauthorizationnumb>19676</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564954-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-1036590</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULO-PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110317</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564955-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351535USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120708</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564956-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NAPPMUNDI-GBR-2012-0011109</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>125 UG/ML, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugdosagetext>4 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SUL HYT</medicinalproduct>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SUL HYT</medicinalproduct>
        <drugdosagetext>5 MG,</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugauthorizationnumb>020553</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564957-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1088902</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564959-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1067396</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORIMOTOR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 5885 (HCV NS5A INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 5885 (HCV NS5A INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULINDAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120327</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE COUGH SYRUP (UNK INGREDIENTS)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 9451 (NS3 PROTEASE INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>21511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GS 9451 (NS3 PROTEASE INHIBITOR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564960-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1085418</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULSE PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN L</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120615</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARENOXACIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564961-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1074608</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 27/APR/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>TOXICITY TO VARIOUS AGENTS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564962-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351625USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564963-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1079518</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564964-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA02448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACQUIRED DIAPHRAGMATIC EVENTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOBILIARY SCAN ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ANXIETY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCELERATED HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011108</drugstartdate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugauthorizationnumb>21762</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564965-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1202USA01572</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL LEUKOPLAKIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STASIS DERMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTEBRAL FORAMINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACET JOINT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONSILLAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERONEAL NERVE PALSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY MALROTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PAPILLOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK LEFT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLITIC MYELOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFILTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0152</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0242</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
        <drugtreatmentduration>2278</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED) (+) VITAMIN D (UNSPECIFIED)</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0805</medicinalproduct>
        <drugindication>GRAVITATIONAL OEDEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>731</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-0805</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564966-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1089301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGONAL RHYTHM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTIVASE</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564967-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-SAVIENT-2012S1000076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KRYSTEXXA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564968-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1088487</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564969-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-011252</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564970-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009137</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564971-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1087746</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY CORNEAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IODINE ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY SENSATION IN EYES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETADINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564972-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1078971</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTEPLASE</medicinalproduct>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADICUT</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564973-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1045721</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugdosagetext>LAST DOS PRIOR TO SAE; 12/JAN/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564974-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1036401</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MACULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564975-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNEVIST</medicinalproduct>
        <drugbatchnumb>03537E</drugbatchnumb>
        <drugauthorizationnumb>019596</drugauthorizationnumb>
        <drugdosagetext>10 ML, ONCE</drugdosagetext>
        <drugindication>NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120801</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564976-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1083926</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHEUMATREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564977-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120603478</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120509</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564978-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-JNJFOC-20120801075</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564979-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120801179</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP ARTHROPLASTY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564980-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120801120</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564981-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120801184</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>APIXABAN</medicinalproduct>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>KNEE OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE/FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564982-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-12P-062-0961565-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER THERAPEUTIC PRODUCTS</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564983-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0963083-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110608</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564984-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0963076-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIXED HEPATOCELLULAR CHOLANGIOCARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LIVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LUNG</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100505</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINE D DCI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>AUTOIMMUNE THYROIDITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564985-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957384-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>2 PACKAGES</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021015</drugauthorizationnumb>
        <drugdosagetext>1 PACKAGES A DAY</drugdosagetext>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHELATED CALCIUM AND MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564986-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ABBOTT-12P-167-0963163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>HAD 6 INJECTIONS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564987-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1043569</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUNTERFEIT DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NON-SMALL CELL LUNG CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564988-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961899-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564993-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080708</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012186202</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>20 MG/ 12.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564994-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184734</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>500/5 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564995-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564996-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184836</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT DROPPER ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564997-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564998-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184843</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugauthorizationnumb>021393</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8564999-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VFEND</medicinalproduct>
        <drugauthorizationnumb>021266</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565000-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.562</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugbatchnumb>1106282</drugbatchnumb>
        <drugauthorizationnumb>021234</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565001-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565002-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>7.5/325 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565003-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185493</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVONORGESTREL + ETHINYL ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>018668</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565004-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185173</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565005-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186510</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THYROID STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugauthorizationnumb>21301</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565006-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184029</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565007-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186477</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565008-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184426</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>800 MG (TOOK FOUR IBUPROFEN TABLETS OF 200MG ONCE), UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565009-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugauthorizationnumb>018482</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565010-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184587</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>050711</drugauthorizationnumb>
        <drugdosagetext>250 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugauthorizationnumb>50711</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565011-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>F76553</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK, 3X/WEEK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VULVOVAGINAL DRYNESS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>2000 (UNIT UNKNOWN)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 (UNIT UNKNOWN)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GELATIN</medicinalproduct>
        <drugdosagetext>1300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL EXTENDED-RELEASE</medicinalproduct>
        <drugdosagetext>240 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>1.25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1000 (UNIT UNKNOWN)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565013-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185769</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565014-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070516</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012186216</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565015-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183966</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugbatchnumb>9GM690</drugbatchnumb>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565016-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.063</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565017-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012186366</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565018-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugbatchnumb>2GM087</drugbatchnumb>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>0.3 MG, ONCE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565019-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184440</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565020-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185319</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>020944</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565021-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1063058</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOCEPREVIR</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565022-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185534</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565024-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012116978</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>F75237</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565025-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185855</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>850 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIBENCLAMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565026-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185937</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>19999</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565027-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185883</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, EVERY 12 HOURS</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>1 UNK, EVERY SIX HOURS</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>275 MG, EVERY 12 HOURS</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565028-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184436</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565029-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080428</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012188211</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOBACCO ABUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>[OLMESARTAN MEDOXOMIL 20 MG]/ [HYDROCHLOROTHIAZIDE 12.5MG] ONCE DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE DAILY</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, ONCE DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565030-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FACIAL PAIN</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565031-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020303</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565032-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070831</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012187058</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>[OLMESARTAN MEDOXOMIL 20 MG/ HYDROCHLOROTHIAZIDE 12.5 MG], 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565033-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184556</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.086</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>20987</drugauthorizationnumb>
        <drugdosagetext>40 MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>IMPAIRED GASTRIC EMPTYING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565034-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186695</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565035-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185702</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565036-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185444</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP PHASE RHYTHM DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565037-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186470</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565038-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012183102</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.506</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECOSE</medicinalproduct>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
        <drugindication>HYPOTHALAMO-PITUITARY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>20825</drugauthorizationnumb>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>1000 MG, 2X/DAY</drugdosagetext>
        <drugindication>HYPERGLYCAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>3 MG, 4X/DAY</drugdosagetext>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZIPRASIDONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565039-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184115</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugauthorizationnumb>022030</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565040-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PENILE SIZE REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHILDREN'S ADVIL</medicinalproduct>
        <drugauthorizationnumb>020589</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565041-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186006</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>18565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PSEUDOEPHEDRINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565042-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1088287</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC KETOACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LATENT AUTOIMMUNE DIABETES IN ADULTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565043-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351569USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>9</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROLEPTIC MALIGNANT SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugauthorizationnumb>073589</drugauthorizationnumb>
        <drugdosagetext>1 DF = 10MG LEVODOPA/100MG CARBIDOPA</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSTONIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565044-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1059626</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPUTUM DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBERCULOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565050-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ROCHE-1066376</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERBILIRUBINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS C</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISPORIVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111114</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565052-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20070226</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012185005</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE EMERGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUINAPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>020125</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565053-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012152624</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>42288</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565054-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185744</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565055-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184210</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565056-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186326</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>250 UG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565057-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugauthorizationnumb>18565</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565058-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186011</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, (DAILY)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, (DAILY)</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, (DAILY)</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, (DAILY)</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565059-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-50794-12061826</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>2.5 GRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565060-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565061-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ROCHE-1074281</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEDOLON A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARCOXIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPRINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONA 200 FOR INJECTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565062-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1089895</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110810</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565063-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1093376</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>JUVENILE ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565064-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1094443</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEMETREXED DISODIUM</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565065-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120705597</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE INJ</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565066-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120303795</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110524</drugstartdate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565067-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-JNJFOC-20120507712</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110204</drugenddate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPRADYNE</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565068-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120520467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS FOR IBD</medicinalproduct>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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    </patient>
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  <safetyreport>
    <safetyreportid>8565069-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
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    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
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    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>54.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYME DISEASE</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>#3 DOSE OF RESTART</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565070-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1092884</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 12/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 12/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANISETRON HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 12/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 12/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120327</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565071-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-1007020</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>12/400 MCG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565072-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1086331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>SPINAL CORD COMPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE-SENNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565073-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1206USA03496</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugauthorizationnumb>021445</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>11</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENECOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565074-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120522</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP003727</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>1800 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>2 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120325</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugdosagetext>1800 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120325</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugdosagetext>2 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.3 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120113</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>5 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.5 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120213</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.5 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120213</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>2 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.3MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITAVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETIZOLAM</medicinalproduct>
        <drugdosagetext>1 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.5 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugdosagetext>1500 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>59</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITAVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugdosagetext>2250 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120113</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROTYM</medicinalproduct>
        <drugdosagetext>100 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
        <drugdosagetext>300 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>10 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>0.5 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>1800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>2 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
        <drugdosagetext>150 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565075-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1092397</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>0.83 TO 1.02 MG/KG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565077-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBRETINAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565078-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1093519</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565079-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-1093143</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE ADMINISTERED ON 27/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565080-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PERRIGO-12US005660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.853</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE POLACRILEX</medicinalproduct>
        <drugbatchnumb>2DE2111</drugbatchnumb>
        <drugauthorizationnumb>076777</drugauthorizationnumb>
        <drugdosagetext>2 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>002</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>805</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565081-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PERRIGO-12GB006412</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOXIC EPIDERMAL NECROLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565082-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BAYER-2012-078420</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1.25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 100 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 1 DF</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565083-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100712</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094759</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565084-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-091172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>99.773</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOLOGICAL TRAUMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugauthorizationnumb>021676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugindication>GENITAL HERPES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565085-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2011-081820</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIPOLAR I DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NSAID'S</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090527</drugenddate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugauthorizationnumb>021098</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMENSTRUAL SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER ANALGESICS AND ANTIPYRETICS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565087-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093419</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565088-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-VERTEX PHARMACEUTICALS INC.-000000000000000956</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: INJECTION</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565089-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VERTEX PHARMACEUTICALS INC.-000000000000000543</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALSARTAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120325</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED, 400X2+200</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120226</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50MG/1000MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565090-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009143</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120305</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120313</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565091-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565092-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IN-GLAXOSMITHKLINE-Z0008658E</companynumb>
    <primarysource>
      <reportercountry>INDIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111116</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OFATUMUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugdosagetext>10MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FEBRILE NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111116</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMBUCIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565093-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-1093061</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>H0139B09,H0111B12</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugbatchnumb>H0139B09,H0111B12</drugbatchnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565097-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012080366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565098-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010070450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACKAGE</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080423</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565099-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012133942</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG DAILY AT NIGHT</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugbatchnumb>V111916</drugbatchnumb>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREXIMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>25 MG DAILY AT NIGHT</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugbatchnumb>V111916</drugbatchnumb>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565100-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012148594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565101-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012081486</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugauthorizationnumb>018482</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110428</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565102-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010095841</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>STARTER PACK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565103-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012171131</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugauthorizationnumb>021719</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565104-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG, 3X/DAY</drugdosagetext>
        <drugindication>MUSCLE RELAXANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>50 MG ONE AND HALF TABLET, EVERY SIX HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, EVERY TWELVE HOURS</drugdosagetext>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565105-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012148261</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugauthorizationnumb>021540</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565106-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565107-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012118504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL PM</medicinalproduct>
        <drugauthorizationnumb>021393</drugauthorizationnumb>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565108-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012150059</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565109-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012175878</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>AZ07101</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEXUAL DYSFUNCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>40 IU, 1X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>40 IU, 2X/DAY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565110-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012181775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.295</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FETTY ACIDS</medicinalproduct>
        <drugdosagetext>350 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>50 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565111-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012051377</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070508</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565112-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012163788</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565114-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.585</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugauthorizationnumb>20472</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120731</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565115-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012121149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565116-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012129557</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugbatchnumb>F48194S</drugbatchnumb>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565117-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180475</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565118-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012163790</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL EXPOSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565119-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012132659</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.086</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugbatchnumb>A207101</drugbatchnumb>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERECTILE DYSFUNCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565120-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012141406</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACEROLA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIJEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565121-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012145112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>^5/325MG^ ONCE A WEEK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugdosagetext>25 MG, EVERY 3 DAYS</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVE INJURY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565122-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012171431</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565123-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012152666</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MERALGIA PARAESTHETICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565124-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012160825</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.154</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL LIQUI-GELS</medicinalproduct>
        <drugbatchnumb>F84042</drugbatchnumb>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>2 X 200 MG CAPSULES, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DEVICE COMPLICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>AURICULAR SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>RASH GENERALISED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565125-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094457</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050758</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565126-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012171976</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>7 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565127-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012168933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>2 MG,DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG,DAILY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>300MG IN A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>90 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565128-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012142752</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADVIL ALLERGY SINUS</medicinalproduct>
        <drugbatchnumb>F71060</drugbatchnumb>
        <drugauthorizationnumb>021441</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565129-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012168915</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>90 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugbatchnumb>F08271S</drugbatchnumb>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>300 MG IN A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565130-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012138453</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG THREE TIMES DAILY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG, 1/2 A DAY FOR A MONTH THEN 1 TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 UG, 1X/DAY INHALED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugdosagetext>250/50 MCG/DOSE, 1 PUFF EVERY TWELVE HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUOFILM</medicinalproduct>
        <drugdosagetext>17 %, 1X/DAY ((ONE) APPLICATION DAILY)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>20 MG, 1 (ONE) TABLET AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>V120427</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565131-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012179337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE COLOUR CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>20597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565132-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565133-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012165062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugbatchnumb>0970111</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565134-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012172287</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565135-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010120516</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070930</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565136-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012172918</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.492</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.075 MG, UNK</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG AM AND 100MG PM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19981001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565137-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012153974</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>12</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>38.549</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>F80816</drugbatchnumb>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>200 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565138-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565139-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012179897</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugindication>VULVOVAGINAL PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugbatchnumb>F76542</drugbatchnumb>
        <drugauthorizationnumb>020216</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>VAGINAL INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565140-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012152148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565141-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-VERTEX PHARMACEUTICALS INC.-000000000000001286</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>DOSAGE FORM: UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565142-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012165237</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, TAKE 1 TABLET 2 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565143-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugauthorizationnumb>020303</drugauthorizationnumb>
        <drugdosagetext>0.3MG/1.5MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENOPAUSE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565144-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGEAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565145-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012163758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565146-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351669USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565147-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1091247</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B10141</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565153-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-ROCHE-1093098</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565154-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012112154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.202</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120429</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>A10587031</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>1-2 PUFFS AS NEEDED</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565155-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012133948</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugbatchnumb>V111916</drugbatchnumb>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREXIMET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1 MG, DAILY AT NIGHT</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAXALT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY AT NIGHT</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565156-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012147783</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G BENZATHINE</medicinalproduct>
        <drugauthorizationnumb>50042</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565157-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012173308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.388</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugbatchnumb>0970111</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>500</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565158-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011137018</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARITAL PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565159-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012151108</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.354</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIKOSYN</medicinalproduct>
        <drugbatchnumb>V120456</drugbatchnumb>
        <drugauthorizationnumb>020931</drugauthorizationnumb>
        <drugdosagetext>250 UG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>65 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN/GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>81 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>20 MG, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565160-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012159678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>1 DROP IN EACH EYE PM DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugbatchnumb>1271110</drugbatchnumb>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ICAPS</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY, 1/2 TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 UG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HCL</medicinalproduct>
        <drugdosagetext>5-20MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugdosagetext>23 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG, 1X/DAY, 1/2 TAB</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORZOLAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 DROP IN EACH EYE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, 1 TAB Q 4-6 PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565161-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012182913</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK, 2X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565162-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17357BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE SHOT</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565163-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1093452</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROLINGUAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE 16/JAN/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINIPRESS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANADEINE (AUSTRALIA)</medicinalproduct>
        <drugdosagetext>30/500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565164-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17026BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565165-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-15133BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FLUTTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565166-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16688BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION NOT FURTHER SPECIFIED</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565167-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17325BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565168-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-1094385</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAPULES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAVOBAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANULOKINE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENDAMUSTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIMETON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110830</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEBOCORTID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565169-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565170-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1090438</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TAMIFLU</medicinalproduct>
        <drugauthorizationnumb>021087</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFLUENZA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090908</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565171-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093448</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565172-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1093558</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANTERIOR CHAMBER CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOPHTHALMITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEICOPLANIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POVIDONE IODINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565173-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1093721</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120314</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565174-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USASP2012047576</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565175-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBRETINAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565176-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011013</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugbatchnumb>1002240</drugbatchnumb>
        <drugauthorizationnumb>021165</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565177-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
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    <companynumb>US-009507513-1208USA000605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565178-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
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    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1207USA009310</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>3285</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565179-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-009507513-2009SP029541</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>021249</drugauthorizationnumb>
        <drugdosagetext>0.5 DF, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090408</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565180-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA01854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
        <drugtreatmentduration>4392</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565181-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094549</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565182-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093199</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL LOAD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565183-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-ROCHE-1090395</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE ABDOMEN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPASMED</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERTUZUMAB</medicinalproduct>
        <drugbatchnumb>H0007</drugbatchnumb>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 4/JUL/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETROX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>B1595</drugbatchnumb>
        <drugdosagetext>DATE OF LAST DOSE PRIOR TO SAE: 04/JUL/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565184-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2012SE53449</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDAZOLAM</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>019627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADSORBED TETANUS TOXOID</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN G</medicinalproduct>
        <drugdosagetext>2400 X 104 U/DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANCURONIUM BROMIDE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565185-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50811</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>MULTIPLE ALLERGIES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURAL MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565186-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094692</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>150/50</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565187-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-1093494</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565188-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20050822</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1094659</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>4X500 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565189-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077611</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00F5U</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565190-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076450</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY WITH CONTRACEPTIVE DEVICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565191-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110203</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094731</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565192-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-GLAXOSMITHKLINE-A0933604A</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIAPHRAGMATIC RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565193-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0950675A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565194-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0950702A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>3.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSISTENT FOETAL CIRCULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MOOD SWINGS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565195-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0979321A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOBUNOLOL HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPITOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565196-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0980293A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO SPINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>1TAB PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565197-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0981715A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugbatchnumb>M100,C564906</drugbatchnumb>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugdosagetext>21NGKM CONTINUOUS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565198-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0984004A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOTRIENT</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>200MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565199-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987599A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565200-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987691A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAMYST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020121</drugauthorizationnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565201-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987796A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugdosagetext>7.5U UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>298</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565202-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0987973A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROSCHISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19971001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565203-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988081A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPOSITION OF THE GREAT VESSELS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESOGEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565204-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988082A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>BIPOLAR II DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565205-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988083A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYLORIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565206-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988084A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565207-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988085A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565208-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988087A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565209-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988088A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565210-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988089A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565211-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988090A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565212-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988091A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLAGIOCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRABISMUS CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINA BIFIDA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565213-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988108A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565214-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988113A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565215-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988114A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL BOWING OF LONG BONES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugdosagetext>500MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HERPES VIRUS INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565216-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988119A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565217-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988123A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950603</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565218-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988124A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040112</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565219-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988125A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565220-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988126A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565221-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988127A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC DILATATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565222-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988129A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565223-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988138A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT PALATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>25MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565224-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988139A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>ANXIETY DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565225-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988141A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL STUDY DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>22465</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL STUDY DRUG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SORAFENIB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOXIFLOXACIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565226-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988145A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA CONGENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL CR</medicinalproduct>
        <drugauthorizationnumb>020936</drugauthorizationnumb>
        <drugdosagetext>12.5MG UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565227-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-VIIV HEALTHCARE LIMITED-B0749982A</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLASMABLASTIC LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>022128</drugauthorizationnumb>
        <drugdosagetext>150MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565228-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0794689A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>1.5TAB PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugauthorizationnumb>021319</drugauthorizationnumb>
        <drugdosagetext>.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC ADENOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>40MG THREE TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565229-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ES-VIIV HEALTHCARE LIMITED-B0804707A</companynumb>
    <primarysource>
      <reportercountry>SPAIN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARAVIROC</medicinalproduct>
        <drugauthorizationnumb>022128</drugauthorizationnumb>
        <drugdosagetext>300MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugdosagetext>1200MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565230-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0809421A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN PLAQUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>1PUFF SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2CAP SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>200MCG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565231-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0811321A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCEOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>B1L5000</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugauthorizationnumb>020089</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORAL HERPES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STEROID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVIPREP</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565232-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120704</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0812492A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POTIGA</medicinalproduct>
        <drugauthorizationnumb>022345</drugauthorizationnumb>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>600MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBAZAM</medicinalproduct>
        <drugdosagetext>15MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565233-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS-GLAXOSMITHKLINE-B0813486A</companynumb>
    <primarysource>
      <reportercountry>SERBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BELLIGERENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565234-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RS-GLAXOSMITHKLINE-B0813489A</companynumb>
    <primarysource>
      <reportercountry>SERBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOGORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KLEPTOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE HCL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565235-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0813774A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCULATORY COLLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugdosagetext>60MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugauthorizationnumb>020444</drugauthorizationnumb>
        <drugdosagetext>.0058MGKM PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOBUTAMINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565237-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0814509A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugdosagetext>1.7G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugdosagetext>1.2G PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565238-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0815427A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BEDRIDDEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPLEGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVOLADE</medicinalproduct>
        <drugauthorizationnumb>22291</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBRAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565239-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GLAXOSMITHKLINE-B0816024A</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCARICIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRAZEPAM</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>1MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENIRAN</medicinalproduct>
        <drugdosagetext>4MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565240-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CZ-GLAXOSMITHKLINE-B0816106A</companynumb>
    <primarysource>
      <reportercountry>CZECH REPUBLIC</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPHYLLIN</medicinalproduct>
        <drugdosagetext>200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100922</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>95</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>1000MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>150MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugauthorizationnumb>022051</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
        <drugdosagetext>30MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565241-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-VIIV HEALTHCARE LIMITED-B0816389A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APLASIA PURE RED CELL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RETROVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019910</drugauthorizationnumb>
        <drugdosagetext>15ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ENCEPHALOPATHY</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120527</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugdosagetext>5ML PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSOLVAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHOLELITHIASIS MIGRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565242-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0816626A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>195MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>20</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>862.5MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOXATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020007</drugauthorizationnumb>
        <drugdosagetext>8MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>120MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>806</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565243-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0816842A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565244-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0816844A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>20007</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>900MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>360MG CUMULATIVE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>125MCG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565245-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0816961A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18MCG PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>250MCG FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565246-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-GLAXOSMITHKLINE-B0816966A</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>500MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>2.5MCG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565247-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0818434A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIXTRA</medicinalproduct>
        <drugauthorizationnumb>021345</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565248-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0818443A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>19</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TEST POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugauthorizationnumb>018703</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565249-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0818625A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MULTIPLE CONGENITAL ABNORMALITIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETROGNATHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUBBING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>250MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>500MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120406</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565250-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RU-VIIV HEALTHCARE LIMITED-B0819097A</companynumb>
    <primarysource>
      <reportercountry>RUSSIAN FEDERATION</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABACAVIR</medicinalproduct>
        <drugauthorizationnumb>020977</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFAVIRENZ</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565251-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-B0819640A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPASTIC PARAPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOVAQUONE</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>020259</drugauthorizationnumb>
        <drugdosagetext>15G SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565252-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0819732A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565253-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0819746A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565254-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-B0819750A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EXPOSURE DURING BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>021142</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>THERMAL BURN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565255-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0819752A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565256-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0820203A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugauthorizationnumb>018603</drugauthorizationnumb>
        <drugdosagetext>3200MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HERPES ZOSTER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCO-CARBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>527</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONTEGEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>103</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIOPAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>78</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565257-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-GLAXOSMITHKLINE-B0820204A</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugauthorizationnumb>014691</drugauthorizationnumb>
        <drugdosagetext>62MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120121</drugenddate>
        <drugtreatmentduration>737</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE TAB</medicinalproduct>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100127</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100205</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>100MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100205</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARANESP</medicinalproduct>
        <drugdosagetext>150MCG PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100205</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565258-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-GLAXOSMITHKLINE-B0820318A</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBLITERATIVE BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CUSHINGOID</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>174</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILEPTAL</medicinalproduct>
        <drugdosagetext>450MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XGEVA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>71</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTASES TO CENTRAL NERVOUS SYSTEM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>40MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BONE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>269</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>172</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565259-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-GLAXOSMITHKLINE-B0820323A</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugauthorizationnumb>020241</drugauthorizationnumb>
        <drugdosagetext>25MG TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TATRATE</medicinalproduct>
        <drugdosagetext>10MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVIAL</medicinalproduct>
        <drugdosagetext>2.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugdosagetext>112.5MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565260-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-GLAXOSMITHKLINE-D0075764A</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MORBILLIFORM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN SUCCINATE</medicinalproduct>
        <drugbatchnumb>TA1638</drugbatchnumb>
        <drugauthorizationnumb>020132</drugauthorizationnumb>
        <drugdosagetext>100MG SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565261-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-Z0012316A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>75.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAZOPANIB</medicinalproduct>
        <drugauthorizationnumb>022465</drugauthorizationnumb>
        <drugdosagetext>800MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPOTECAN</medicinalproduct>
        <drugauthorizationnumb>20981</drugauthorizationnumb>
        <drugdosagetext>2.5MG CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1000ML SINGLE DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEHYDRATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111015</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOSYN</medicinalproduct>
        <drugdosagetext>4.5G FOUR TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111020</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAGMIN</medicinalproduct>
        <drugdosagetext>5000UNIT PER DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565262-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12071491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565263-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094608</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPEREOSINOPHILIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565264-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-12060391</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTI-THYMOCYTE GLOBULIN NOS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIEMETIC SUPPORTIVE CARE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugdosagetext>750 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugdosagetext>280 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSODIOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
        <drugdosagetext>480 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>35 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugdosagetext>800 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565267-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-21880-12072517</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>554</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565269-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>LT-ALEXION PHARMACEUTICALS INC.-A201201413</companynumb>
    <primarysource>
      <reportercountry>LITHUANIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHACALCIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROPOETIN</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKERS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMAN GROWTH HORMONE, RECOMBINANT</medicinalproduct>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACFI</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIDASOLINE RECEPTOR AGONISTS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>600 MG, 2 DAYS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565270-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201428</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565271-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201201404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565272-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095898</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565273-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012162598</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT PACKAGING ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugbatchnumb>2GM103</drugbatchnumb>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565274-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012180807</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.506</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugdosagetext>50 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugbatchnumb>C10136130</drugbatchnumb>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565275-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012176004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565276-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012147081</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugbatchnumb>C111421</drugbatchnumb>
        <drugauthorizationnumb>021131</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565277-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-CELGENEUS-129-C5013-12072605</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER TRANSITIONAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETO 50 ZK</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 GRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERTENSIF SR</medicinalproduct>
        <drugdosagetext>15 MICROGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRINIVIL</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111122</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120426</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 GRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACIPIL</medicinalproduct>
        <drugdosagetext>4 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565278-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095019</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565279-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201309</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.9</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR INVASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE BREAKAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565280-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201201422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565281-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION PHARMACEUTICALS INC.-A201201397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>900 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565282-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010689</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN G BENZATHINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MACRODANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IODINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINOCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOMYCIN SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAMELOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXSORALEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEOSPORIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENTAMICIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>19766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565283-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA001271</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565284-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP026205</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120226</drugenddate>
        <drugtreatmentduration>41</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120318</drugenddate>
        <drugtreatmentduration>62</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROTYM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>FORMULATION POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>FORMULATION POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>FORMULATION POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120408</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120513</drugenddate>
        <drugtreatmentduration>77</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIHYDROERGOCRISTINE MESYLATE</medicinalproduct>
        <drugdosagetext>FORMULATION POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>FORMULATION POR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURODIN (DIHYDROERGOCRISTINE MESYLATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565285-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2010SP038514</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METRORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>DYSFUNCTIONAL UTERINE BLEEDING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>MENSTRUAL CYCLE MANAGEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565286-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565287-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351536USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565288-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1095069</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565289-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201433</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATHETER SITE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565290-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ALEXION-A201201398</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>39.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARATHYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>37.5 MG, QD AT BEDTIME PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIDODRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>PRN TO STAY FOCUSED</drugdosagetext>
        <drugindication>DISTURBANCE IN ATTENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugdosagetext>COMPOUNDED DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugdosagetext>5 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>75 ?G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>1200 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELAMER CARBONATE</medicinalproduct>
        <drugdosagetext>1600 MG, TID WITH FOOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>100 MG/ML, WITH DIALYSIS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG, QD AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugdosagetext>10000 UT, QW X3 DOSES PER WEEK VIA DIALYSIS ACCESS</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2 MG BEFORE DIALYSIS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>12.5 MG, PRN QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>6.25 MG, QID PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>180 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, PRN AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>7.5 MG, QD IN AM PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMTRACE ESTRADIOL</medicinalproduct>
        <drugdosagetext>1.8 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>40 MG, PRN</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565291-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PR-ALEXION PHARMACEUTICALS INC.-A201201430</companynumb>
    <primarysource>
      <reportercountry>PUERTO RICO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOTRACHEAL INTUBATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLIRIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HAEMOLYTIC URAEMIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565292-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1095556</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565293-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1095835</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565294-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-009266</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120422</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565295-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095172</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565296-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50505</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565297-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1082461</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IDIOPATHIC PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOKUNALIN</medicinalproduct>
        <drugdosagetext>HOKUNALIN:TAPE</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>TRACHEAL DILATATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALOXI</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCTIVE COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugdosagetext>DOSAGE IS UNCERTAIN.</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>LUNG ADENOCARCINOMA RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111029</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565298-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095777</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>7 COURSES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090706</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565299-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MPIJNJ-2012-01394</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugbatchnumb>OF545C</drugbatchnumb>
        <drugdosagetext>1620 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110908</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>108-49381</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>2 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111005</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111013</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565300-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1095834</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565301-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010237</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE EVENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID 30 MIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565302-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095904</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565303-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095194</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL THERAPEUTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565307-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090803</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>091490</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565308-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000265</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565309-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP046637</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPAREUNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>NUTRITIONAL SUPPORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565310-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1095041</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE WAS CYCLE 2 ON 22/JUN/2012.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE WAS CYCLE 2 ON 22/JUN/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565311-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ROCHE-1095858</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERNIA REPAIR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565312-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-ROCHE-1095044</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565313-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095551</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110429</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565314-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E7389-02259-CLI-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111108</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111108</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER RECURRENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO LIVER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111108</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADENOSINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111108</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111114</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALAVEN</medicinalproduct>
        <drugauthorizationnumb>201532</drugauthorizationnumb>
        <drugindication>METASTASES TO BONE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565315-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095461</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATIONS OF TRANSPLANTED KIDNEY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELL CEPT</medicinalproduct>
        <drugauthorizationnumb>50722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMULECT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>176MG IN MORNING 150MG IN EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugdosagetext>613 UG/L</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565317-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-1094878</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugauthorizationnumb>021455</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565318-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565319-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-BAYER-2012-078335</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>4015</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565320-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076789</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565321-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091123</drugenddate>
        <drugtreatmentduration>279</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>2 MIU, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100815</drugenddate>
        <drugtreatmentduration>54</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565322-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095920</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565323-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076320</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YAZ</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BEYAZ</medicinalproduct>
        <drugauthorizationnumb>022532</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111212</drugenddate>
        <drugtreatmentduration>524</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YASMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111212</drugenddate>
        <drugtreatmentduration>524</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>325 MG, UNK</drugdosagetext>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565324-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565325-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTRAZENECA-2012SE53756</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULSE ABSENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PUPILLARY REFLEX IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>005</drugadministrationroute>
        <drugindication>ANAESTHESIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565326-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>.5714 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565327-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565333-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012188061</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565334-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1094077</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MACULAR DEGENERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565335-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012169635</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RESISTANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>019950</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugauthorizationnumb>019949</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565336-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565337-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PURDUE-USA-2012-0090804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRAIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMUNICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE DRUG OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20553</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEROIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565338-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187620</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECTOR</medicinalproduct>
        <drugbatchnumb>1012072</drugbatchnumb>
        <drugauthorizationnumb>021234</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL</medicinalproduct>
        <drugdosagetext>100 MG (50MG TWO TABLETS), 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565339-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187914</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565340-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1095617</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLICATED TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>7.5 -10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE PLUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565341-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565342-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1095663</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565343-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351530USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>EAR INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>33803067A</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565344-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094859</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>APPARENT DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS ALLERGIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565345-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095709</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE TIMING UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOSPORINE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>TRANSPLANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565346-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565347-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1094794</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CYTOKINE RELEASE SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565348-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096847</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROCEPHIN</medicinalproduct>
        <drugauthorizationnumb>050585</drugauthorizationnumb>
        <drugindication>LUNG INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565349-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21660-12031689</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>227 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugauthorizationnumb>021660</drugauthorizationnumb>
        <drugdosagetext>227 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugdosagetext>4 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYFUL</medicinalproduct>
        <drugdosagetext>3 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>11 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>227 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABRAXANE</medicinalproduct>
        <drugdosagetext>227 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROTIZOLAN</medicinalproduct>
        <drugdosagetext>.25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565350-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110531</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096689</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565351-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MA-ROCHE-1096895</companynumb>
    <primarysource>
      <reportercountry>MOROCCO</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565352-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095956</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>022257</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565357-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-EISAI INC-E7389-02527-CLI-FR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565358-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008661</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>3477</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>3477</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565359-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096113</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL ANTINEOPLASTIC AGENT</medicinalproduct>
        <drugdosagetext>COHORT 2</drugdosagetext>
        <drugindication>NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL ANTINEOPLASTIC AGENT</medicinalproduct>
        <drugdosagetext>COHORT 2 AT REDUCED DOSE</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565360-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1095972</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE RECURRENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB EMTANSINE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAPATINIB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565361-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>RHINITIS SEASONAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565362-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0055962</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100811</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565363-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565364-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110701</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096697</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565365-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-ROCHE-1096548</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>44</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565366-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-SANOFI-AVENTIS-2012SA039172</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC RETINOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BED REST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA ALZHEIMER'S TYPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugbatchnumb>1F899A</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugdosagetext>STARTED ABOUT 8 YEARS AGO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>1F899A</drugbatchnumb>
        <drugdosagetext>STARTED ABOUT 8 YEARS AGO</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565367-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>KERATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL ANTINEOPLASTIC AGENT</medicinalproduct>
        <drugdosagetext>COHORT 2</drugdosagetext>
        <drugindication>NEOPLASM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL ANTINEOPLASTIC AGENT</medicinalproduct>
        <drugdosagetext>COHORT 2 AT REDUCED DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugdosagetext>LOADING DOSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565368-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1096144</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111222</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCICHEW D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100831</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565369-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12070343</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE SODIUM PHOSPHATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEPARINA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120504</drugenddate>
        <drugtreatmentduration>168</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565370-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095207</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER TRANSPLANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565373-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1096866</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565374-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095964</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565375-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-ROCHE-1096927</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>MACULOPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565376-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CELGENEUS-167-21880-12053528</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VASCULAR OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565377-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-CELGENEUS-056-C5013-12072919</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565378-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096694</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565379-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-14686BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>201363A,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>250 NR</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565380-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096697</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565381-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096686</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565382-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565383-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000022729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565385-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1095965</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565386-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351140USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>020717</drugauthorizationnumb>
        <drugdosagetext>800 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugdosagetext>7.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565387-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1096191</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUCENTIS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565388-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12050099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE MARROW FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25-15MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565389-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096497</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19910101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565390-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1096555</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565391-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1096553</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>GLIOBLASTOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565392-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-MSD-1206USA00938</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>0.25 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMELIAN</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROTEIN URINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>20560</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNOSIDES)</medicinalproduct>
        <drugdosagetext>48 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELCITONIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APLACE</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KREMEZIN</medicinalproduct>
        <drugdosagetext>4 G, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALANTA</medicinalproduct>
        <drugdosagetext>9 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERSANTINE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565393-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2010SP006063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL MYCOTIC INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>UNCLEAR WHETHER 16JAN RENEWAL OR START DATE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>50 ?G, QD</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugdosagetext>150 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VULVOVAGINAL MYCOTIC INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080214</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>2 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>UTERINE LEIOMYOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080207</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>Q 8 HRS PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM DS</medicinalproduct>
        <drugdosagetext>160/800 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CYSTITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPROX DS</medicinalproduct>
        <drugdosagetext>550 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071213</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE (+) HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/12.5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE POLISTIREX (+) PHENYLTOLOXAMINE POLISTIREX</medicinalproduct>
        <drugdosagetext>1 TSP</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565394-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FI-ROCHE-697662</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugdosagetext>FREQUENCY:3+3 TABLET (3000MG) PER DAY ON DAYS 1-15, THEN 7 DAY REST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565395-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110512</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096686</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565396-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-INCYTE CORPORATION-2012IN001400</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JAKAFI</medicinalproduct>
        <drugauthorizationnumb>202192</drugauthorizationnumb>
        <drugdosagetext>10 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYELOFIBROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565397-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1096658</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALFENTANIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018654</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEVOFLURANE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HARTMANN'S SOLUTION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GRANISETRON</medicinalproduct>
        <drugauthorizationnumb>020239</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565398-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-751749</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAROTID GLAND ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>DOSAGE INCREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABATACEPT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B20051</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B20051</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B20051</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugbatchnumb>B20051</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>DRUG REPORTED: OMEGA 3</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565399-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351368USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENABLEX</medicinalproduct>
        <drugdosagetext>7.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugauthorizationnumb>020717</drugauthorizationnumb>
        <drugdosagetext>800 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565400-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565401-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110124</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-755676</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDE ATTEMPT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>NOT PRESCRIBED.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>OVERDOSE</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COPEGUS</medicinalproduct>
        <drugauthorizationnumb>021511</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugdosagetext>TAKEN AT NIGHT, NOT PRESCRIBED.</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100913</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110103</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>NOT PRESCRIBED.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565402-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugauthorizationnumb>021304</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565403-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096694</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565404-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110905</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-800553</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLORECTAL CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>STRENGTH FORM WAS 100MG/4ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110624</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEMOTHERAPY NOS</medicinalproduct>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>COLORECTAL CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565405-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012156724</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugbatchnumb>0970111</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565406-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012119119</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugbatchnumb>0923091</drugbatchnumb>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565407-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012184237</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LUMBAR HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565408-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012186586</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEURALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugauthorizationnumb>19949</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CANDIDURIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMOXICILLIN TRIHYDRATE</medicinalproduct>
        <drugdosagetext>1 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565409-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012168102</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565410-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012159519</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MENTAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565411-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012136248</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAIR GROWTH ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR COLOUR CHANGES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>10000 IU, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>500 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE HYDROCHLORIDE/CHONDROITIN SULFATE</medicinalproduct>
        <drugdosagetext>1500MG/1200MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugauthorizationnumb>004782</drugauthorizationnumb>
        <drugdosagetext>0.3 ONCE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>1000 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCERA AVH</medicinalproduct>
        <drugdosagetext>1515 MG, 2/3 PER DAY</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565412-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012183981</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESSEL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080619</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565413-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012171775</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUADRIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>18989</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugindication>GASTRIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALKA-SELTZER</medicinalproduct>
        <drugdosagetext>2 DF, ONCE</drugdosagetext>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565414-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012154382</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN + HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12.5MG/150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>020402</drugauthorizationnumb>
        <drugdosagetext>1 DF, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565415-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012182624</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565416-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012159067</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>91.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT SUBSTITUTION ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG, 1X/DAY, AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugbatchnumb>2070312</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>80 MG, 1X/DAY, AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565417-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012173157</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>20 MG, 1 TABLET AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK MG, 1X/DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
        <drugdosagetext>50 MG IN THE MORNING AND 50 MG AT NIGHT</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565418-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012155715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565419-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012172950</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565420-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186646</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugbatchnumb>2ZP6378</drugbatchnumb>
        <drugdosagetext>250/50 MCG, 1 PUFF(S) 2X/DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565421-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012168919</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>90 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>2 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>300 MG IN A DAY (FREQUENCY UNKNOWN)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565422-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012166246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565423-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012185802</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565424-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012137645</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565425-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2012SA046400</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PUMP RESERVOIR ISSUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDENOFALK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19950101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM/COLECALCIFEROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565426-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012161647</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>15 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1.5 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZULFIDINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>500 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565427-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012149238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565428-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012164968</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.19</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATIC OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILIOPANCREATIC BYPASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565429-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>V120431</drugbatchnumb>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>C120034</drugbatchnumb>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>100 MG, DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugbatchnumb>C111557</drugbatchnumb>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1 PILL TWO TIMES A DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>1 PILL TWO TIMES A DAY</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565430-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012136307</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>75 MG, 3X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565431-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012136494</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD FOLLICLE STIMULATING HORMONE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TESTOSTERONE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOCRINE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugauthorizationnumb>020895</drugauthorizationnumb>
        <drugdosagetext>100 MG, 1 TABLET AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565432-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012157007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPHRENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugindication>STRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugauthorizationnumb>018276</drugauthorizationnumb>
        <drugdosagetext>1 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANIC ATTACK</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565433-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565434-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110505</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1096682</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565435-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2012163628</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565436-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012167980</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565437-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012152311</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEILITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>LIP DRY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC STRAWBERRY</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugindication>LIP DRY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC</medicinalproduct>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>100 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHAPSTICK CLASSIC</medicinalproduct>
        <drugbatchnumb>E14396</drugbatchnumb>
        <drugdosagetext>UNK, AS NEEDED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 UG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565438-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012169232</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALKORI</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugindication>LUNG NEOPLASM MALIGNANT</drugindication>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565439-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184184</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2 IN THE MORNING 1 IN THE AFTERNOON AND 2 IN THE EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565440-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012159532</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565441-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012162747</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 3X/DAY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>1-2MG, 1X/DAY</drugdosagetext>
        <drugindication>MUSCLE SPASTICITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugauthorizationnumb>20235</drugauthorizationnumb>
        <drugdosagetext>300 MG,DAILY</drugdosagetext>
        <drugindication>EHLERS-DANLOS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugauthorizationnumb>020235</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565442-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-PFIZER INC-2012144084</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEXSIG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugauthorizationnumb>021992</drugauthorizationnumb>
        <drugdosagetext>100 MG, IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRO-BANTHINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565443-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012169178</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugindication>EROSIVE DUODENITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORMS (IN THE MORNING)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EROSIVE OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565444-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012160431</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565445-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012187791</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRODERM</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIDAZIDE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugauthorizationnumb>017892</drugauthorizationnumb>
        <drugdosagetext>1 DF, TOTAL DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>15 GTT, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565446-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BURNING SENSATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565447-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012160455</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565448-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012140792</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEMYELINATING POLYNEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYMYCARD</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565449-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2012183910</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>3 UG, 1X/DAY (ONE DROP EACH EYE)</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>INTRAOCULAR PRESSURE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565450-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-1207GBR003012</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETHAMBUTOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111220</drugenddate>
        <drugtreatmentduration>191</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZASITE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PYRIDOXINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIFATER</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565451-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1203USA01480</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080501</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565452-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-ROCHE-782273</companynumb>
    <primarysource>
      <reportercountry>SLOVENIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>FREQUENCY: 2 CYCLES OF 4 WEEKS MONOTHERAPY AFTER AUTOLOGOUS TRANSPLANTATION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MANTLE CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565453-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-SANOFI-AVENTIS-2012SA046394</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090601</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>10-30 IU/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>INSULIN-REQUIRING TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565454-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096495</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565455-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-756131</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100331</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100331</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
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        <drugenddate>20101110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100526</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100623</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090826</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALCION</medicinalproduct>
        <drugdosagetext>AS NEEDED 0.25 MG A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090603</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101013</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101013</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>SINGLE USE, DOSAGE DURING A DAY: 25 MG</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091118</drugstartdate>
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        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090212</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
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        <drugenddate>20100113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090730</drugstartdate>
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        <drugenddate>20100113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
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        <drugenddate>20100924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100721</drugstartdate>
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        <drugenddate>20100721</drugenddate>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565456-1</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20041122</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1094673</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VASCULITIS</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>2X 500 MG</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
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    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565457-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1091667</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
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        <drugenddate>20120627</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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        <drugenddate>20120627</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CALCIUM GLUCONATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
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        <drugenddate>20120627</drugenddate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLON CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
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      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
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    <safetyreportid>8565458-5</safetyreportid>
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    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-ROCHE-740082</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
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    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
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    <receiver></receiver>
    <patient>
      <patientweight>52</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
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      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
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        <drugstartdate>20101109</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
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        <drugenddate>20101109</drugenddate>
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        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101105</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINZAPARIN</medicinalproduct>
        <drugdosagetext>TDD 10000 UNITS</drugdosagetext>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANEXAMIC ACID</medicinalproduct>
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        <drugstartdate>20101114</drugstartdate>
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      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOCETAXEL</medicinalproduct>
        <drugbatchnumb>DOA142, DOA152</drugbatchnumb>
        <drugdosagetext>DOSE LEVEL:100 MG/M2; LAST DOSE PRIOR TO SAE 26 OCT 2010, PERMANENTLY DISCONTINUED ON 16 NOV 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
        <drugbatchnumb>B2098</drugbatchnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE : 26 OCT 2010, PERMANENTLY DISCONTINUED ON 16 NOV 2010</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN K TAB</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565459-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1090928</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:09/JUL/2012</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIVE LUBRICANT EYE DROPS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DRY EYE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugindication>LOWER RESPIRATORY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PIPERACILLIN AND TAZOBACTAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUININE SULFATE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN AND CODEINE PHOSPHATE</medicinalproduct>
        <drugdosagetext>30/500; 120MG/4G</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:09/JUL/2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugindication>VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENOGRASTIM</medicinalproduct>
        <drugindication>NEUTROPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE:09/JUL/2012; MAINTENANCE FOR 24 MONTHS</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COTRIM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565460-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110225</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PT-ROCHE-754077</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD IMMUNOGLOBULIN A INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVE AGENTS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565461-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ABBOTT-11P-062-0841261-00</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXERCISE TOLERANCE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETA BLOCKING AGENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>40MG EOW PEN</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111017</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565462-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120722</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ELI_LILLY_AND_COMPANY-IL201207006835</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>1 DF, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>1 DF, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONEX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PANIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1000 MG/M2, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERLOTINIB HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA                                  /HKG/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565463-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-1037132</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLICLAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANIBIZUMAB</medicinalproduct>
        <drugdosagetext>LAST DOSE PRIOR TO SAE: 19/JAN/2012</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETIC RETINAL OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565464-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ASTRAZENECA-2012SE53773</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugauthorizationnumb>006488</drugauthorizationnumb>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>LOCAL ANAESTHESIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565465-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-783717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.584</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565467-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095794</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugdosagetext>THIRD LINE</drugdosagetext>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565468-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012159518</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565469-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>VE-PFIZER INC-2012159517</companynumb>
    <primarysource>
      <reportercountry>VENEZUELA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565470-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-SANOFI-AVENTIS-2012SA012553</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTEROGRADE AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALTERED STATE OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugauthorizationnumb>21081</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SOLOSTAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DEVICE THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565471-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1034499</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugdosagetext>FIRST THERAPY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19870618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19891019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19880601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19890306</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19920908</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19930105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565472-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ROCHE-1064273</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TILIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZELBORAF</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565473-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0917461-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSFUSION REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 EVERY 2 WEEKS FOR 2 DOSES</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROBIOTICA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 TO 60 MG ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>50 TO 150 MG ONCE DAILY</drugdosagetext>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565474-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351561USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugdosagetext>EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565475-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0957142-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>6019933</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565476-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ABBOTT-12P-028-0963101-00</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTERIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>INCREASED, UNSPECIFIED AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXEZE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURO-FER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOLOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>DECREASED, UNSPECIFIED AMOUNT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3-4 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEPROLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 2</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565478-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351385USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugauthorizationnumb>080936</drugauthorizationnumb>
        <drugdosagetext>300MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>LATENT TUBERCULOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISONIAZID</medicinalproduct>
        <drugauthorizationnumb>080936</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565479-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0938292-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE VESICLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SCAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE MALFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFRIN</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTIVELLA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>151992E</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIZATIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VAGIFEM</medicinalproduct>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTIFENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565480-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0962029-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE REMOVAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGIOEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>SURGERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120622</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>ADMINISTERED VIA PCA PUMP IN HOSPITAL</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565481-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-AMGEN-CANSP2012042965</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENIC INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION PLEURAL CAVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID LUNG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTOPERATIVE WOUND INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>337</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565483-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50845</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565484-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080122</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565485-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-GENZYME-CERZ-1002489</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>21</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAUCHER'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>C1178A02</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>400 U, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GAUCHER'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>15 U/KG, Q3W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>28 U/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>29 U/KG, Q 3-4W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>30 U/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEREZYME</medicinalproduct>
        <drugauthorizationnumb>020367</drugauthorizationnumb>
        <drugdosagetext>60 U/KG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565486-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50902</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4314</patientonsetage>
      <patientonsetageunit>803</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugauthorizationnumb>019777</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COGNITIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565489-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012172218</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>125 MG PER TEN MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>750 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIO-RESPIRATORY ARREST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>90243</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHERMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPOTHERMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565490-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012175506</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ZYGOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>050467</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565491-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012172210</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>125 MG, PER 10 MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIO-RESPIRATORY ARREST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>750 MG, DAILY</drugdosagetext>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHERMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>90243</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHERMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565492-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19830421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-83050280</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565493-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120525</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA005867</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DR. SCHOLL'S INGROWN TOENAIL PAIN RELIEVER</medicinalproduct>
        <drugindication>INGROWING NAIL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DR. SCHOLL'S INGROWN TOENAIL PAIN RELIEVER</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565494-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19830829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-83080246</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565495-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>19860616</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-009507513-86010445</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHROMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugauthorizationnumb>017555</drugauthorizationnumb>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugtreatmentduration>4745</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565496-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1201USA04014</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHROMIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOALBUMINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>REVERSIBLE AIRWAYS OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>3812</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9359</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM (MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIED))</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19700101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565497-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NO-UCBSA-055854</companynumb>
    <primarysource>
      <reportercountry>NORWAY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565498-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059047</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICAL DEVICE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565499-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16671BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565500-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351660USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565501-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16667149</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TABLET PHYSICAL ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugauthorizationnumb>081295</drugauthorizationnumb>
        <drugdosagetext>TABS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVIGEL</medicinalproduct>
        <drugdosagetext>FORMULATION-PATCH</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>FORMULATION-INHALATION POWDER</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565502-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-20785-11010011</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>1.3 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELPHALAN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>200 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>5 MICROGRAM/KILOGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>1.3 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>1 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BORTEZOMIB</medicinalproduct>
        <drugdosagetext>.7 MILLIGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugdosagetext>10 MICROGRAM/KILOGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>4 G/M2</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565503-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>MX-SANOFI-AVENTIS-2012SA053626</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021081</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110826</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565508-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072089</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565509-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120714290</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARUNAVIR ETHANOLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRENOCORTICAL HORMONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREZISTA</medicinalproduct>
        <drugauthorizationnumb>21976</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIRETROVIRAL THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITONAVIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG ERUPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565510-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20111011313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>ONCE IN EVERY 6-7 WEEKS. THE PATIENT WAS ON INFLIXIMAB SINCE 3.3 YEARS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565511-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120712950</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110713</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565512-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120607779</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IIM074PI</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IIM074PI</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>IIM074PI</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565513-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715138</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>15</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>1.2-1.4ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565514-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715183</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565515-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20120800364</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADENOCARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>STRENGTH 100 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565516-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120713089</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CACHEXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>BKM85014</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565517-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715214</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565518-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120715297</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROCTOCOLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565519-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715132</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565520-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-039317</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>150</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UTERINE POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugdosagetext>400MG WEEKS AT 0, 2 AND 4 WEEKS FOLLOWED BY  200MG Q2W (AT WEEKS 6 TO 50)</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110623</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110929</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565521-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-AMGEN-BRASP2012047009</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugdosagetext>50 MG, WEEKLY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565527-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351597USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TINESTA</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565528-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA004080</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELANOSIS COLI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABYRINTHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010626</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071024</drugenddate>
        <drugtreatmentduration>2311</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111127</drugenddate>
        <drugtreatmentduration>131</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101214</drugenddate>
        <drugtreatmentduration>1013</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565530-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120614543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT PACKAGING ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDIARRHEAL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugauthorizationnumb>019835</drugauthorizationnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALLERGY TO PLANTS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugbatchnumb>235868;UNSPECIFIED</drugbatchnumb>
        <drugdosagetext>SOMETIMES 2 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565531-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120209055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA-3 FATTY ACIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565532-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.43</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565533-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120715368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>11</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565534-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713216</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>ONCE IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565535-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120513616</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA, PARANOID TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111121</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>FULL BLOOD COUNT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565536-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120800020</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA</medicinalproduct>
        <drugauthorizationnumb>021999</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565537-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120801235</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEVICE LEAKAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>CBB4H00</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565538-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120608729</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugdosagetext>04-APR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugdosagetext>24-MAY</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugdosagetext>24-APR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugdosagetext>3-MAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugdosagetext>14-MAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565539-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120412564</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GRANULOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565540-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>DK-JNJFOC-20120513266</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRUXAL</medicinalproduct>
        <drugdosagetext>WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PALIPERIDONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSANTIN</medicinalproduct>
        <drugdosagetext>50 MG X 3 WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBASMIN TURBUHALER</medicinalproduct>
        <drugdosagetext>WHEN NEEDED</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565541-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120609041</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565542-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120614761</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565543-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713134</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>112.49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565544-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120714580</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EMBOLISM VENOUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ORTHOPEDIC PROCEDURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565545-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709474</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALL OTHER MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565546-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120801084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565547-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120801186</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565548-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120713159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565549-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057211</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LEFT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565550-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351608USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugbatchnumb>PAB09A</drugbatchnumb>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugdosagetext>1-2 INHALATIONS EVERY 4-6 HOURS AS NEEDED</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565551-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1002664</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>80 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565557-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010544</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEBURIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565558-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351533USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565560-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
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    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00EVU</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565561-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00CDS</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120731</drugenddate>
        <drugtreatmentduration>177</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565562-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800189</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL LOSS OF WEIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAKTHROUGH PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL-100</medicinalproduct>
        <drugbatchnumb>1112789</drugbatchnumb>
        <drugauthorizationnumb>019813</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PROCEDURAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565563-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-JNJFOC-20120800169</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICORETTE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565564-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120504554</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INADEQUATE DIET</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565565-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-JNJFOC-20120711964</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGWHEEL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>10 MG IN THE MORNING AND 15 MG IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565566-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120610605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565567-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120706228</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>BXG4TJ1</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOPRESS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565568-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-JNJFOC-20120511442</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565569-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120711091</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>AKATHISIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HALOPERIDOL DECANOATE</medicinalproduct>
        <drugauthorizationnumb>018701</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565570-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120611404</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>DCA001</drugbatchnumb>
        <drugauthorizationnumb>019872</drugauthorizationnumb>
        <drugdosagetext>2 CAPLETS EVERY 4-6 HOURS, 4 CAPLETS ON 09-JUN-2012 AND 2 CAPLETS ON 10-JUN-2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOOTHACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565573-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012073682</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.889</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACCIDENT AT WORK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>200 MG, DAILY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERTRALINE</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>20699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 3X/DAY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565574-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012121483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>1-2 TABLETS EVERY 6 HOURS WHILE AWAKE FOR 3 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>UNSPECIFIED, 1 OCCASIONALLY FOR FEW MONTHS 2-3 YEARS AGO</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugauthorizationnumb>018989</drugauthorizationnumb>
        <drugdosagetext>3-4 DAILY FOR FEW MONTHS 2-3 YEARS AGO</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL PM</medicinalproduct>
        <drugdosagetext>CAPLET, 1 CAPLET NIGHTLY AT BEDTIME FOR ABOUT 4 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>21928</drugauthorizationnumb>
        <drugdosagetext>TABLET, FOR 3 WEEKS 3-4 YEARS AGO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugdosagetext>CAPLET, 2 CAPLETS EVERY 6 HOURS WHILE AWAKE FOR</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>UNKNOWN, AS NEEDED EITHER DAILY OR TWO TIMES IN A DAY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565575-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011009096</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090924</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AGGRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090926</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090926</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugindication>AGGRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugindication>LETHARGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020919</drugauthorizationnumb>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565576-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012084635</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGESTIVE CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIRUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>050778</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030320</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOMIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565578-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012110693</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTISOCIAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>100MG/150 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>225 MG, 1X (12 HR RELEASE) CAPSULE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugauthorizationnumb>020151</drugauthorizationnumb>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565579-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012116869</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INLYTA</medicinalproduct>
        <drugbatchnumb>1271110</drugbatchnumb>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565580-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011028200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOMICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTPARTUM DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugdosagetext>75 MG, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090323</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL S</medicinalproduct>
        <drugdosagetext>ONE TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090302</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugauthorizationnumb>020825</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENESIN</medicinalproduct>
        <drugdosagetext>600 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090302</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090324</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.25 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090317</drugenddate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>100 MG, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090315</drugenddate>
        <drugtreatmentduration>60</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>0.5 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565581-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010092594</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TAKAYASU'S ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE NEONATAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CORONARY ARTERY MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GYNAZOLE</medicinalproduct>
        <drugdosagetext>2 %, ONE APPLICATION</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMAGEN FORTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565582-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012172220</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM QT PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VECURONIUM BROMIDE</medicinalproduct>
        <drugauthorizationnumb>90243</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHERMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPOFOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPOTHERMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>125 MG PER TEN MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMIODARONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>750 MG, DAILY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CARDIO-RESPIRATORY ARREST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565583-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011293445</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERY ATRESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER DEVELOPMENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE TIMING UNSPECIFIED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHWACHMAN-DIAMOND SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALLOT'S TETRALOGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATENT DUCTUS ARTERIOSUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT AORTIC ARCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL FOR DATES BABY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD LAG</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARACHNODACTYLY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSMORPHISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICROGNATHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL NOSE MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE TORSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL ANOMALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOSPADIAS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIGEORGE'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DOUBLE OUTLET RIGHT VENTRICLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PACHYGYRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INGUINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 UNKNOWN UNITS, UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>50 MG, HALF TABLET PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031013</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565584-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-PFIZER INC-2012188220</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALICYLIC ACID</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565585-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012103395</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.782</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565586-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011204403</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugauthorizationnumb>73676</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugauthorizationnumb>019839</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565587-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010079660</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOSTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 MG, UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565588-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-PFIZER INC-2011263956</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, EVERY 24 HOURS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111003</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED DOSAGE, TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111007</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565589-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2011259717</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOMEGALOVIRUS ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100823</drugenddate>
        <drugtreatmentduration>176</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100306</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE SODIUM</medicinalproduct>
        <drugauthorizationnumb>011719</drugauthorizationnumb>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100308</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>35.2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONCOVIN</medicinalproduct>
        <drugdosagetext>1.971 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugdosagetext>70 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugdosagetext>422.4 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100302</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565590-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2011281671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>005% 1 DROP EACH EYE DAILY</drugdosagetext>
        <drugindication>CATARACT OPERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565591-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012127294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugauthorizationnumb>011839</drugauthorizationnumb>
        <drugdosagetext>UNK, EVERY 3 MONTHS</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>150 UG, EVERY 48 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY</drugdosagetext>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILAUDID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>300 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG, DAILY</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugdosagetext>500 MG, EVERY 8 HOURS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565592-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12072763</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN INSULATARD NPH NORDISK</medicinalproduct>
        <drugdosagetext>9-12 UNITS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>5.7143 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>15 OR 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 OR 325 MG</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565593-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2007SP017987</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
        <drugdosagetext>100 ?G, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071105</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL - USP (WARRICK)</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565594-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2009SP040437</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060821</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METICORTEN</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>15 MG, QW</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565595-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1205USA04582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOULDER ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH EXTRACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERITONSILLAR ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KNEE ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>4410</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030418</drugenddate>
        <drugtreatmentduration>1354</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENLAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030422</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>2654</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101011</drugenddate>
        <drugtreatmentduration>961</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565596-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1105USA00586</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INADEQUATELY CONTROLLED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCISION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLONIC POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS MEDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugdosagetext>IV GIVEN YEARLY</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051001</drugenddate>
        <drugtreatmentduration>244</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20031101</drugenddate>
        <drugtreatmentduration>1006</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565597-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057420</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100525</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565598-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-TEVA-350287ISR</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXCORIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>PRN (TAKEN AS REQUIRED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MORPHINE</medicinalproduct>
        <drugdosagetext>PRN (TAKEN AS REQUIRED), NOT TAKEN BETWEEN 21/6/12 - 27/6/12</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugauthorizationnumb>76759</drugauthorizationnumb>
        <drugdosagetext>PRN (TAKEN AS REQUIRED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>2.5 - 5MG AS REQUIRED (PRN)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565599-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-NOVEN-12GB005019</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.46</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>021299</drugauthorizationnumb>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugauthorizationnumb>021299</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565600-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120609772</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565601-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120301123</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STELARA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565602-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-JNJFOC-20120800841</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugauthorizationnumb>021123</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565603-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120801343</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PERITONITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugdosagetext>0, 2, AND 6 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565604-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-JNJFOC-20120517527</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPROLACTINAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>PALIPERIDONE PALMITATE</medicinalproduct>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565605-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120603313</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAY 63 DOSE GIVEN ON AN UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAY 1 DOSE GIVEN AT UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020272</drugauthorizationnumb>
        <drugdosagetext>EVERY BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAY 35 DOSE GIVEN AT UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugdosagetext>DAY 91 DOSE GIVEN ON AN UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>DAY 8 DOSE GIVEN AT UNSPECIFIED DATE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565606-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>IT-JNJFOC-20120605160</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOPOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20272</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120608</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565607-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-062752</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED ACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HYPOMOTILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPILEPSY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugdosagetext>DAILY DOSE : 150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE : 3000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPILEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugauthorizationnumb>021035</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE : 6000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>DAILY DOSE : 400 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE : 1000 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAPP</medicinalproduct>
        <drugdosagetext>DAILY DOSE : 20 MG AS NECESSARY</drugdosagetext>
        <drugadministrationroute>054</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565608-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011835</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugindication>OESOPHAGITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABACAVIR SULFATE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALTEGRAVIR</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CANCIDAS</medicinalproduct>
        <drugauthorizationnumb>021227</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OROPHARYNGEAL CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETRAVIRINE</medicinalproduct>
        <drugindication>HIV INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565609-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP011815</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565610-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565611-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-PFIZER INC-2012187583</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugauthorizationnumb>019787</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugauthorizationnumb>19668</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIROFUR</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565612-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012186063</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>87</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565613-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17196BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>2 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565614-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17127BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565615-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351588USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565616-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA002007</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>HMLX78</drugbatchnumb>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565617-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011571</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>150 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugdosagetext>800 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565618-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA008663</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>7366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
        <drugtreatmentduration>7366</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565619-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-CUBIST-2012S1000640</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CASPOFUNGIN ACETATE</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VORICONAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POSACONAZOLE</medicinalproduct>
        <drugindication>CANDIDIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOFLOXACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565620-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0057801</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE IMBALANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565621-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-BRISTOL-MYERS SQUIBB COMPANY-16402901</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugbatchnumb>465</drugbatchnumb>
        <drugdosagetext>RECENT INFUSION 19JAN12</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>RECENT INFUSION 15JUL11(1000 MG/M2, 7440MG)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE FUMARATE</medicinalproduct>
        <drugdosagetext>1DF=2 UNIT NOS</drugdosagetext>
        <drugindication>ANTIALLERGIC THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120119</drugenddate>
        <drugtreatmentduration>329</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>1DF=8 UNIT NOS</drugdosagetext>
        <drugindication>IMMUNE SYSTEM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120119</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>RECENT INFUSION 15JUL11 (100 MG/M2, 180MG)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEAD AND NECK CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTACID THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565622-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>-CUBIST-2012S1000641</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>PYREXIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565623-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16814832</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>33</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PSYCHIATRIC SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>IM DEPOT</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15MG FRM 03JUL12</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565624-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-CUBIST-2012S1000642</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565625-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16795171</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugauthorizationnumb>018768</drugauthorizationnumb>
        <drugdosagetext>ON DAY1 + 3</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>019880</drugauthorizationnumb>
        <drugdosagetext>ON DAY1</drugdosagetext>
        <drugindication>SMALL CELL LUNG CANCER STAGE UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565626-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BG-BRISTOL-MYERS SQUIBB COMPANY-16723454</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCHIZOPHRENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>INTERRUPTED:06JUN2012(7DAYS)</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565627-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012110140</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
        <drugauthorizationnumb>021437</drugauthorizationnumb>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEBURIC</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>1500 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>21446</drugauthorizationnumb>
        <drugdosagetext>75 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCIATICA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS FUMARATE</medicinalproduct>
        <drugdosagetext>100 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>003</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORNER</medicinalproduct>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROL</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUVELA</medicinalproduct>
        <drugdosagetext>200 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565628-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012117795</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, UID/QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565629-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565630-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16754236</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>1DF:10/500 UNITS NOS</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugbatchnumb>1A516A</drugbatchnumb>
        <drugauthorizationnumb>020758</drugauthorizationnumb>
        <drugdosagetext>1DF = 300/12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565631-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-15398449</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERNATIONAL NORMALISED RATIO INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL COLIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROTIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HCL</medicinalproduct>
        <drugdosagetext>1DF = 0.5 TAB X3</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugdosagetext>1DF = .125</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>DURATION OF THERAPY:27 YRS VARIABLE DOSAGES</drugdosagetext>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19830101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASITONE</medicinalproduct>
        <drugdosagetext>1DF =1 TAB</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565632-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-BRISTOL-MYERS SQUIBB COMPANY-16825697</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565633-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BRISTOL-MYERS SQUIBB COMPANY-16721961</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugdosagetext>FORMULATION-INTEBAN SP</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE/ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugdosagetext>18MAR11,01APR11,15APR,13MAY,10JUN11</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIFLUNISAL</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DORAL</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROZEREM</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PL GRANULES</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugdosagetext>INJ</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>TAB</drugdosagetext>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>CAP</drugdosagetext>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565634-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16808990</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>84</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROLOGICAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDEP</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565635-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565636-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-CUBIST-2012S1000643</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>BACTERAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>HAEMODIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>RENAL FAILURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEROPENEM</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>HEPATIC FAILURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565637-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A817828A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A761967C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565638-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201202003425</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1470 MG, OTHER</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPYRONE TAB</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMZAR</medicinalproduct>
        <drugbatchnumb>A923438</drugbatchnumb>
        <drugauthorizationnumb>020509</drugauthorizationnumb>
        <drugdosagetext>1580 MG, CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565639-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008485</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>A911663C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>16 U, EACH MORNING</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>A911663C</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>6 U, EACH EVENING</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565640-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007224</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.295</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 50/50</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565641-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008120</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG MIX 75/25</medicinalproduct>
        <drugbatchnumb>A941993E</drugbatchnumb>
        <drugdosagetext>26 U, QD</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565642-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201205010776</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565643-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007824</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A897158A</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>UNK, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565644-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008163</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A910305O</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565645-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008200</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MOTOR DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>32 U, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565646-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201205001068</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565647-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201207000506</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDENOFALK</medicinalproduct>
        <drugdosagetext>3 MG, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>A963481</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugdosagetext>21.75 MG, EACH MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565648-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>ZA-ELI_LILLY_AND_COMPANY-ZA201207007643</companynumb>
    <primarysource>
      <reportercountry>SOUTH AFRICA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK, EACH EVENING</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPID MODIFYING AGENTS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>20 U, TID</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565649-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201208000551</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugbatchnumb>A936099A</drugbatchnumb>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565650-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-ELI_LILLY_AND_COMPANY-CH201207003404</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT TAMPERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugbatchnumb>A888934</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>20 IU, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>TYPE 1 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565651-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013076</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>019658</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565652-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP000176</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THROMBOPHLEBITIS SUPERFICIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090308</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565653-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1205USA02868</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LUNG CANCER METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDODONTIC PROCEDURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>2920</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565654-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-2009SP010002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugauthorizationnumb>020503</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565655-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CH-CUBIST-2012S1000644</companynumb>
    <primarysource>
      <reportercountry>SWITZERLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>DOSE UNIT:U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>LIVER DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565656-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CUBIST-2012S1000646</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120520</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565657-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-JNJFOC-20120800827</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565658-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SE-JNJFOC-20120712869</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FIBROMYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST VIRAL FATIGUE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AN UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIRCADIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugauthorizationnumb>021121</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565659-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857900-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565660-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858034-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565661-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858074-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERCHLORHYDRIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565662-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858082-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565663-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858020-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565664-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858083-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565665-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857908-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.462</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVELLA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565666-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857828-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110924</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565667-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857842-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>177.06</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN EVENING WITH DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565668-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565669-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883354-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565670-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883359-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPOD BITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLO IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565671-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935325-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREMATURE BABY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>MATERNAL EXPOSURE TIMING UNSPECIFIED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565672-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883408-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BC POWDER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>GENE MUTATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565673-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858406-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565674-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883362-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565675-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858629-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565676-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ABBOTT-12P-056-0956601-00</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYTOLYTIC HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOXICITY TO VARIOUS AGENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOGENIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY DISTRESS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARKA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020591</drugauthorizationnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPEGIC 1000</medicinalproduct>
        <drugindication>PLATELET AGGREGATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRANDOLAPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565677-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858590-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565678-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883396-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565679-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883267-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565680-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858176-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565681-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844732-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565682-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883293-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPRELAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565683-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883441-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565684-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883315-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565685-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883287-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565686-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883365-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>2 UNKNOWN BP MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565687-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844815-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>ADVERSE REACTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONTRAST DYE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565688-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883387-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROQUINE SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565689-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844760-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565690-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883318-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565691-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0655174-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565692-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883414-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565693-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858971-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565694-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565695-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120523</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0716276-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORISPAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565696-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883658-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565697-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0643906-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565698-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565699-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872570-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>3 BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565700-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883695-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565701-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883845-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565702-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110917</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0649161-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565703-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883836-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565704-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872095-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NOON</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565705-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883890-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565706-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883858-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565707-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0657853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565708-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883448-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ACID REFLUX MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565709-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872335-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565710-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883726-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.382</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565711-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883878-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT SUPPER TIME</drugdosagetext>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565712-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873003-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111027</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565713-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844739-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>5/500 MG TWICE A DAY AS NEEDED</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED HYPERTENSION MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565714-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844765-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYPROSEN</medicinalproduct>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565715-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883720-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565716-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872489-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565717-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0712166-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY  DAILY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565718-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844757-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565719-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844743-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION FOR MEMORY</medicinalproduct>
        <drugindication>MEMORY IMPAIRMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565720-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0725997-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110328</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOSONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110516</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565721-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844823-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565722-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858936-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565723-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844857-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565724-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058125</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>SCLERODERMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565725-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565726-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872483-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565727-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844872-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10/12.5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTOFF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565728-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565729-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844929-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG X 2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565730-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873458-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565731-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844936-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565732-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE PATCHES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565733-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872988-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565734-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0648003-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565735-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0658398-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QAM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECLACENACE</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565736-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0638152-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>APOLIPOPROTEIN B INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565737-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872104-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXACAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565738-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859256-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE IN THE MORNING AND EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE IN THE MORNING AND EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565739-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0691727-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565740-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT ONE TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565742-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844998-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110709</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565743-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872955-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565744-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663087-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565746-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858084-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565747-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858256-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565748-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565749-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858087-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565750-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858427-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCO-HYDROCODONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIRIPTYLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>32 TABLETS TAPERING DOSE JUL 2011 CAN'T REMEMBER WHY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TREXIMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROBAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565751-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858189-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565752-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.382</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYLL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565753-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935330-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>KALETRA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021906</drugauthorizationnumb>
        <drugdosagetext>1 COURSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 COURSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTIVIRAL TREATMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565754-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857911-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN POWDER MIXED WITH WATER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110923</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565755-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858375-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565756-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858164-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.278</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565757-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858264-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.462</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565758-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858014-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>BEFORE SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565759-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858170-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG / 1 TABLET; AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565760-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858401-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565761-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858411-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565762-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883263-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565764-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858024-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565765-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858172-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEIZURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugindication>EX-TOBACCO USER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565766-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858403-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>125.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME FOR 2 WEEKS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - TWO AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKE TWO 10 MINS PRIOR TO TAKING NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565767-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-072516</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565768-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858399-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>OIL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000-200 MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565769-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858070-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPINIROLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAPINIROLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>2 TABS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565770-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883356-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - WITH EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>WITH EVENING MEAL OVER 4 WEEK PERIOD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>WITH EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>250 MG - WITH EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565771-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858925-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565772-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858449-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565773-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565774-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883272-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565775-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883701-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565776-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0666120-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DOSE UNKNOWN</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYER COATED ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565777-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0858931-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565778-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873322-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565779-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872982-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565780-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844931-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>01206AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PALMETTO</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>01206AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110630</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565781-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565782-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20/25MG QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG QHS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565783-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873597-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565784-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845005-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565785-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872948-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG - ONE IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN THE MORNING, 1 AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110904</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565786-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873351-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565787-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872334-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565788-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862798-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIRE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565789-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863094-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565790-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873312-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565791-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845051-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAGAMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC ZEGRID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG X 2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY INJECTIONS</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565792-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845052-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3-6-9</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565793-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873328-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565794-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873218-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565795-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863258-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>INSULIN SLIDING SCALE 12-16 UNITS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/25MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565796-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872745-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565797-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873590-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565798-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842148-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565799-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845009-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 1200 PLUS 1000 IUD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565800-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873376-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CARDIAC ARREST</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565801-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862272-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565802-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885381-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DAILY DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565803-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873371-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565804-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861738-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.978</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565805-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565806-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013165</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020163</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565807-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861323-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TWO AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565808-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012574</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERITONITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNCTIONAL GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTAZIDIME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PERITONITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565809-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013171</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565810-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565811-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565812-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013145</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565813-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013263</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565814-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013182</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565815-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842142-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXEDRINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565816-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862294-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>132.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565817-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861311-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565818-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842298-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565819-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885377-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565820-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873600-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565823-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859000-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565824-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0663572-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 10MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 40</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 800MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPOXYPHENE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVILIDE</medicinalproduct>
        <drugdosagetext>300/25 DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>DAILY DOSE: 75MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565825-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0709513-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B6</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL SA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565826-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0732703-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565827-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-CUBIST-2012S1000441</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN HCL</medicinalproduct>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CUBICIN</medicinalproduct>
        <drugauthorizationnumb>021572</drugauthorizationnumb>
        <drugindication>OSTEOMYELITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565828-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872874-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565829-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845013-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565830-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872339-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASETERIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565831-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872927-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565832-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872330-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565833-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872098-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565834-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872774-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565835-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862587-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565836-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885372-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565837-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565838-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873372-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INCREASED TO 1000 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>Q HS / DOSE DECREASED FROM 1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565839-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872985-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>25MG AT NIGHT, 12.5MG IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565840-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885368-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565841-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872471-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIAL STENOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565842-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873394-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565844-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845012-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVENING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVENING, INTERRUPTED FOR THREE WEEKS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565845-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873391-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565846-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565847-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872808-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565848-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872974-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER DINNER, EVENING MEAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565849-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863315-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565850-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873392-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565851-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873603-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYS NASAL SPRAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565852-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861732-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDANE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JOLESSA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565853-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845120-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>3-4 TIMES PER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565854-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873444-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565855-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872925-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565856-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863241-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565857-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862105-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565858-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873593-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565859-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862271-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APPLE CIDER</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUAIFENISEN</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLDEN SEAL EXTRACT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B 100</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565860-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845114-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROPIPATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565861-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845018-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565862-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845023-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565863-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842152-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565864-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565865-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013289</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565866-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013185</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565867-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012605</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565868-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013294</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FULL BLOOD COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565869-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565870-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013162</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565871-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013268</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565872-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862263-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.646</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPLETE VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565873-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873360-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>PATCH</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565876-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565877-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0706203-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565878-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873135-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565879-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0708783-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565880-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845116-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLTHENIDATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565881-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0723054-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN HORMONES</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>FIBROMYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565882-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872987-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565883-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0718343-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565884-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0729675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECORTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110511</drugstartdate>
        <drugtreatmentduration>90</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETH GLYCOL</medicinalproduct>
        <drugdosagetext>DAILY IN 8 OZ OF WATER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565885-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862266-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTOFF OVER THE COUNTER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565886-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872106-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565887-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0694445-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNSPECIFIED DOSE; 3 TABLETS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>RANDOM USE</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565888-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0734903-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565889-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845085-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110807</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565890-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873315-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565891-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0834393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565892-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0662366-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG AT BEDTIME + 500MG EVERY AM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565893-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872479-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565894-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872778-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565895-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0834391-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG - AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG - AT NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565896-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873503-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEZAPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565897-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111009</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862254-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TITRATED DOSE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565898-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873715-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565899-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565900-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872118-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565901-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872977-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN VITAMIN SUPPLEMENT</medicinalproduct>
        <drugindication>GALLBLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565902-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873302-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565903-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862216-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/20.5MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugdosagetext>15/500MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORSATAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILACOR XR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565905-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872785-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565906-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842207-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE DAILY AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE CREAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUICE PLUS VITAMINS AND VEGETABLES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE DAILY WITH SUPPER</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565907-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565908-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ONE DAILY IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565909-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848783-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>49.032</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565910-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862548-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIRBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565911-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863332-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565912-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862610-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM ZINC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRASTERONE</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHALIPOIC ACID</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC ACIDOLPHILLUS</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRAPEFUIT SEED EXTRACT</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRENAL SUPPLEMENT SERAPHOS</medicinalproduct>
        <drugdosagetext>AFTERNOON</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURAL E</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIC</medicinalproduct>
        <drugdosagetext>IN THE MORNING, ABD 5</drugdosagetext>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIMINERAL VITAMIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
        <drugdosagetext>EXTRACT, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX FISH OMEGA 369</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565913-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849150-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565914-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862545-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 TABS QHS</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110925</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565915-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842685-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565916-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862800-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565917-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849134-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565918-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863090-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565919-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863199-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565920-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849152-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565921-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862609-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135.75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565922-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848611-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565923-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863196-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565924-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848794-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>PREVIOUSLY AT BEDTIME,NOW IN THE MORNING</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565925-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848398-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE OTHER MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565926-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863188-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565927-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865789-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565928-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0835394-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565929-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>58</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY AT NIGHT TIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565930-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848659-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110820</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565931-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842170-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110727</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565932-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873719-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565933-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866246-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565934-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842212-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565935-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0840619-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1/2 HR PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565936-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL RESECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565937-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849212-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110811</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565938-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849160-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INTERRUPTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565939-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863305-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110928</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565940-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565941-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842686-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565942-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849010-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF PRESSURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565943-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886875-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565944-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842366-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565945-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842329-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.836</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565947-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886905-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENEXIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565948-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887381-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565949-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848475-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565950-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848244-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565951-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848752-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565952-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848859-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.934</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LUMBAR PUNCTURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565953-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013273</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565954-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862389-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565955-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848219-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565956-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION FOR HIATAL HERNIA</medicinalproduct>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565957-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861861-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565958-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862386-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565959-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873713-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENERIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565960-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885363-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ONCE DAILY IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565961-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862077-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565962-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845142-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565963-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845124-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>DIABETES PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565964-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848295-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ATRIOVENTRICULAR BLOCK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110818</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE VITAMINS</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565965-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862172-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135.29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565966-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845208-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110725</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRIZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565967-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848411-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>INSULIN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565968-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861966-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BERFORE DOSE OF NIASPAN, AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOIDENTICAL HORMONE THERAPY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565969-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862406-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.578</patientweight>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110930</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565970-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885383-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565971-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863193-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565972-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861906-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.886</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1/2 TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565973-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRIP STRENGTH DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SOD DR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565974-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIFLEX WITH D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DECREASED APPETITE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTERNA</medicinalproduct>
        <drugdosagetext>150/160 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 600 MG WITH D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCETIRIZINE DIHYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUROPATHY B</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565975-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842601-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFLAVONOID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565976-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848706-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTIC</medicinalproduct>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIINFLAMMATORY MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565977-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842037-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565978-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863083-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN DRUG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565979-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842622-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/20MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565980-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565981-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565982-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863089-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565983-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848598-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565984-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849139-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565985-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863197-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN PAIN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565986-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848753-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565987-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848796-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565988-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565989-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848711-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565990-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866450-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565991-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842689-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME, INTERRUPTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110129</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565992-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886541-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETES MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIURETICS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565993-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863318-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110926</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565994-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565995-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848846-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565996-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565997-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848593-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565998-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842361-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8565999-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887113-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566000-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849068-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566001-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845336-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.646</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KERATOSIS PILARIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG, DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566002-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887096-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566003-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020183</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566004-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013284</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566005-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862212-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566006-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873622-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVEFREE OTC</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugdosagetext>60 MG ER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566007-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861981-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>138.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF  NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HYPERTENSION MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN WATER PILL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566008-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861231-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566009-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861743-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566010-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848221-00</companynumb>
    <primarysource>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566011-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862329-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566012-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566013-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848390-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566014-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863092-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566015-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111008</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862211-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566016-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863153-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111010</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566017-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861860-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566018-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863177-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566019-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863086-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566020-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845212-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566021-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848676-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40-60MG/DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566022-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111007</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861969-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG EVERY OTHER DAY: 2.5MG OTHER DAYS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566023-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861214-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566024-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848403-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566025-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0838889-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566026-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845262-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566027-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863044-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566028-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848838-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566029-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0841032-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2-750MG TABLETS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566030-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862335-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566031-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863398-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR BEFORE NIASPAN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566032-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848822-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566033-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYSAL</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VD3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUANAPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC TABLETS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566034-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTORIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>STATIN MEDICATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566035-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111010</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0862605-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT 1 AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566036-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842371-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.204</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566037-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842215-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING W/BREAKFAST</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING W/FOOD, INTERRUPTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566038-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566039-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887306-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566040-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845358-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566041-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866467-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>MID-DAY</drugdosagetext>
        <drugindication>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>FIVE DAYS PER WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566042-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866579-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566043-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845278-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT PACKAGING ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>02146AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECLINED LIST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566044-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866472-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566045-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848416-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>119.86</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETES MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566046-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566047-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845662-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566048-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877924-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566049-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848843-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULORIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566050-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845457-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566051-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566052-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877907-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXLANSOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566053-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>V3 D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566054-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845579-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566055-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850802-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PUSTULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566056-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110905</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851865-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566057-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845643-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40 DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566058-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887664-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>4 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566059-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851136-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566060-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MDL-2012ML000073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>YAWNING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCLONUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSURE DURING BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUPRENORPHINE</medicinalproduct>
        <drugauthorizationnumb>090622</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566061-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866475-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566062-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566063-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851871-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566064-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVI FOR MEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566065-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849298-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566066-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851552-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEMETIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566067-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851672-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VULVOVAGINAL PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN MORNING, 1 IN EVENING, 2000 MG/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566068-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851538-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>SINCE DISCONTINUED LIPITOR</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DISCONTINUED AT TIME OF FLUSHING EPISODE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566069-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851008-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566070-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110903</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566071-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866486-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELENIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566072-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878806-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566073-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886824-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOESTRIN FE 1/20</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566074-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879082-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566075-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878688-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566076-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850984-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566077-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851149-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>INSULIN PUMP</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566078-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887441-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566079-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848225-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.198</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORCE AC</medicinalproduct>
        <drugdosagetext>10/320/25</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566080-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849128-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.432</patientweight>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKEN HALF HOUR BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566081-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887088-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 TABLETS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKES WITH AMLODIPINE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAMENDA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566082-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849038-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566083-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848267-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566084-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>LIPIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>LIPIDS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugindication>AFFECTIVE DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566085-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887377-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566086-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849178-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566087-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845452-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566088-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848327-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110820</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566089-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886873-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566090-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887044-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566091-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110820</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848937-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566092-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887304-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566093-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848591-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566094-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886561-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566095-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866571-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40 DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566096-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887662-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566097-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849067-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566098-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850872-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BREATH ODOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566099-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848537-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566100-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887102-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACNE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPANA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566101-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865959-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566102-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851090-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566103-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848651-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566104-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887643-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5/20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566105-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845439-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566106-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110823</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TWICE A DAY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566107-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845328-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.198</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566108-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110809</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845310-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566109-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849383-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ONCE IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN COATED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566110-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845343-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566111-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848519-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566112-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878956-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566113-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLERGY PLUS SINUS BY (RITE AID) (NON-ABBOTT)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566114-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849004-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566115-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566116-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845462-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566117-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886619-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566118-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845592-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566119-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887090-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566120-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>RECENTLY STARTED TAKING DURING THE DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566121-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566122-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866463-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISTYLOIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566123-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866458-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566124-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866650-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>4 HOURS AFTER TAKING NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566125-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865913-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPLANT SITE DISCHARGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110925</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566126-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566127-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DEPRESSION MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANXIETY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566128-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866176-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060902</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566129-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866576-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566130-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845305-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC LORATIDINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566131-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887042-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INHALERS</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566132-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849173-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG AT HS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566133-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848407-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566134-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886539-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566135-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887305-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566136-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865780-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566137-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851123-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DISPENSING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG AT SUPPER + 2000 MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566138-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851150-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566139-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845633-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566140-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866190-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111008</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566141-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845451-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566142-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887416-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566143-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845408-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1/4 TABLETS 100 SYSTOLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566144-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849012-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566145-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878179-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566146-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIGAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>5 INJECTIONS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566147-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845291-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110808</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566148-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886879-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.094</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TECTURNAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKEN NEAR OR AFTER SUPPER MEALS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566149-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848854-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.296</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110819</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566150-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878342-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566151-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566152-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878046-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA RED KRILL OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C WITH ROSE HIPS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566153-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849208-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110806</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110806</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566154-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878336-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566155-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878701-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110929</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>SLOWLY INCREASED TO CURRENT DOSE OF 4 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COAGULOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566156-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850818-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566157-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850841-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566158-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851534-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETIRIZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566159-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110821</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848974-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>HYPERPARATHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GONTROPIN INJ</medicinalproduct>
        <drugindication>HYPOPARATHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>INSULIN RESISTANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566160-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877883-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566161-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851581-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566162-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851798-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566163-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugindication>HYPOAESTHESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CERTRALINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566164-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871416-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566165-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870878-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566166-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866466-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566167-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111127</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566168-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879076-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566169-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850833-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566170-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885991-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566171-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863973-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566172-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885781-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSINOPRIL SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>4 DOSES</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566173-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879321-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566174-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866487-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566175-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886509-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566176-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864229-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>03288AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TOOK ONLY ONE DOSE AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TOOK AT SAME TIME WITH NIASPAN, AND GIVEN IN ER.</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111007</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566177-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885406-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566178-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870706-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566179-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850756-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566180-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863929-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566181-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863970-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566182-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885894-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OYSCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TITRATED TO 2 TABS OF 1000MG HS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566183-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870685-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELEXIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566184-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866673-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566185-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864055-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MIN PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566186-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864388-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG AT BED TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566187-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886421-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566188-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870902-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123.94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566189-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850760-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566190-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864867-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566191-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885769-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566192-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865375-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566193-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863431-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HTC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566194-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850943-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566195-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865118-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.026</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METORPROLOL</medicinalproduct>
        <drugdosagetext>? MG PO QDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>? MG PO QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566196-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863498-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG PO AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566197-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885458-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566198-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865696-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566199-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851049-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>128.03</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566200-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871103-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC SUPPLEMENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC PILLS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566201-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865499-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 HOUR PRIOR TO BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566202-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885410-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566203-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887005-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>2 AT BEDTIME, 2 IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566204-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885723-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566205-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878180-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12 SUBLINGUAL</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY SHOTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DURING THE DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566206-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851236-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE/CHONDROITIN</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566207-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851009-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHEWABLES WITH VITAMIN K</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566208-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887303-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCLE RELAXANTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>REDUCED TO 81MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566209-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863681-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.358</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566210-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851381-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566211-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850987-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME FOR ONE MONTH</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566212-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887280-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566213-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885441-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE W/METFORMIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADJENTA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566214-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877957-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566215-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887091-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>6 OR 7 VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566216-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851590-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566217-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851409-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566218-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885460-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE TAKING NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SUPPLEMENTS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566219-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878953-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>BLADDER DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugindication>ABNORMAL SENSATION IN EYE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566220-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886475-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566221-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879085-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566222-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887442-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110530</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566223-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863601-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566224-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879272-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19970101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566225-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851582-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566226-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863688-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566227-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878235-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566228-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845264-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566229-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851524-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN AM AND 1 AT PM, DAILY</drugdosagetext>
        <drugindication>CATHETERISATION CARDIAC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110906</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugdosagetext>5/20, DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>ANGINA PECTORIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566230-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879072-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>3 DAYS PER WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>4 DAYS PER WEEK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566231-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878782-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566232-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871102-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566233-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845347-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110703</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLENDIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566234-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878912-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566235-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566236-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845453-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAPILLARY FRAGILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINE OUTPUT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN  1 AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENAZOPYRIDINE HCL TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
        <drugdosagetext>INSERT</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566237-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878364-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.302</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566238-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878888-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>05256AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>STOPPED MEDICATION FOR 2 WEEKS. 20-30 MINUTES BEFORE NIASPAN THERAPY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>05256AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP. 3 MONTH SUPPLY FROM MAIL ORDER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKES DURING DINNER IN EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>20-30 MINUTES BEFORE NIASPAN THERAPY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566239-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111012</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566240-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2009UW13710</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TYPE 1 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GESTATIONAL DIABETES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100 MCG PER DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANCEF</medicinalproduct>
        <drugdosagetext>EVERY 8 HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566241-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886485-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566242-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110804</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/80 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DHEA/PREG</medicinalproduct>
        <drugdosagetext>20/25</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>A-THYROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566243-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851835-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566244-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566245-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871082-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566246-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871099-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566247-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851870-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY DOSE 500 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566248-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878178-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>163.44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566249-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871423-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566250-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886494-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566251-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866457-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>500/40MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566252-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851802-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566253-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879087-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY AT LUNCH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566254-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566255-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886476-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566256-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866478-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566257-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851849-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566258-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879069-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERVE DAMAGE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566259-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871413-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTC ACID REFLUX MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD THINNER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566260-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863772-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566261-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866586-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566262-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878045-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIRIX</medicinalproduct>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566263-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871252-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566264-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863793-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566265-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871028-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566266-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878711-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566267-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866482-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566268-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PNEUMIONIA VACCINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111102</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566269-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864292-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION FOR EYE PROBLEM</medicinalproduct>
        <drugindication>RETINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SHINGLES VACCINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION FOR EYE PROBLEM</medicinalproduct>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION INJECTIONS</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566270-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870901-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.756</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>AORTIC OCCLUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566271-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846926-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110813</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566272-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888751-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALLERGY TO CHEMICALS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TXMNT PAUSED D/T AE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORDIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566273-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869321-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>EYE PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>RHINITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566274-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869119-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2-500MG TABLETS AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugdosagetext>2 INJECTION EVERY DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566275-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885800-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CARDIAC OPERATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111219</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566276-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888994-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566278-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868683-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566279-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879287-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>POLYMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME, WILL RESTART ONCE PRESCRIPTION IS FILLED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>WILL STOP ONCE NIASPAN IS REFILLED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566280-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863967-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566281-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566282-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846714-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566283-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847505-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566284-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351382USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>79</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEFT ATRIAL DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugauthorizationnumb>079090</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>360MG DAILY; EXTENDED RELEASE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566285-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879080-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG QHS, 500 MG QAM</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566286-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864335-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTOPREVE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566287-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869314-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.278</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HEART RATE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566288-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847462-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT AFTER ASA</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY NIGHT BEFORE NIASPAN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566289-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-TEVA-350857USA</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>4</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARTIAL SEIZURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>074488</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugauthorizationnumb>074488</drugauthorizationnumb>
        <drugdosagetext>5.2 ML; 15MG/ML TAKE 2.6 ML TWICE DAILY FOR 1 MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566290-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNISON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566291-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863785-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS NOT REPORTED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566292-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878707-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566293-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869432-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT SPRAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566294-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847633-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>160 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>80 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1700 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566295-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847651-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566296-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865238-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>BLOOD URIC ACID</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566297-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869439-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566298-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864814-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATTENALOL LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566299-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869438-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566300-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847665-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566301-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879327-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ASPIRINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566302-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865277-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.204</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566303-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887844-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566304-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846640-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566305-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847838-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566306-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870898-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.794</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566307-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865338-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566308-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888575-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566309-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846878-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.014</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ MAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MENEST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALAGEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566310-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566311-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885786-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566312-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865345-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>HIATUS HERNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566313-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETIC PILLS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111223</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566314-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846941-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTEPRO</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMENARIS NASAL SPRAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>Q HS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOCAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566315-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846685-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566316-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885444-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - IN THE AFTERNOON</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566317-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864397-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566318-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-165-0866489-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566319-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846431-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566320-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566321-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885449-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566322-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566323-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868433-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUDAFED 12 HOUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566325-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888810-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566326-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869042-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICINES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566327-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869057-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIFEX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566328-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885798-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFFIENT</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111214</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566330-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865071-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYMBALTA</medicinalproduct>
        <drugdosagetext>30MG AND 60MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVALOG INSULIN PUMP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUTALBAPAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566331-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugdosagetext>1.8 EVERY AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>0.4 DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAMIR</medicinalproduct>
        <drugdosagetext>42 AT HS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS DAILY FOR 30 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 - 500 MG SAMPLES DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY FOR 30 DAYS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MIN PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566332-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865362-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566333-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885463-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>Q AM FOR ONE WEEK THEN CHANGE TO HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>CHANGE TO Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566334-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863427-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUNDORNATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER SUPPER</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugindication>GASTRIC PH DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INTERRUPTED DUE TO AE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111012</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566335-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566336-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868460-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566337-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865289-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566338-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871486-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>DAILY MONDAY THROUGH FRIDAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>71/2MG ON SUNDAYS</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566340-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871175-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566341-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851148-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566342-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868341-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566343-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871266-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.278</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566344-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868339-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566345-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886447-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566346-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868554-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566347-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851411-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566348-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886438-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY AM WITH BREAKFAST</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566349-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111005</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIOVUE</medicinalproduct>
        <drugindication>EYE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566350-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885796-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINARA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566351-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868800-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566352-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885473-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566353-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110902</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851520-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566354-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868676-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIOFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLURAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566355-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864722-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111013</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566356-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868740-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566357-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851585-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILODIPINE BESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERIAL STENT INSERTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566358-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871492-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566359-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868549-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZENICAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENACOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566360-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865115-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566361-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868880-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>05246AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566362-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851644-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566363-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871033-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENECAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566364-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868452-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHAPPED LIPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10/325</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYER ADVANCED ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREZVISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELZENTRY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111023</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566365-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865698-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566366-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847643-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>N500 MG PO DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>135 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>30 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>220 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566367-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878349-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVALORD</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110928</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566368-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863776-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>3 X 81 MG TABS QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566369-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868687-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566370-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865518-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566371-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847659-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566372-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879089-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC ALLERGY MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566373-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864058-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566375-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868398-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566376-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566377-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846935-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>50/500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566378-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0878175-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566379-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864612-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS VIT D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAPAYA ENZYME</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566380-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846428-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1 1/2 TABLET IN MORNING AND NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566381-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868694-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566382-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868311-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>07093AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111022</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>COMPOUNDED 120 MG AND 90 MG AND ALTERNATES DOSAGE STRENGTHS QOD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566383-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851804-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566384-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863958-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566385-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868733-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566386-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868342-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566387-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847180-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566388-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851859-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY HS</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566389-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863879-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDS NOT REPORTED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566390-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869318-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.026</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566391-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847502-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>250 MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566392-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566393-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0851853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>30 MIN AFTER ASPIRIN + EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110905</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CREAM</medicinalproduct>
        <drugdosagetext>TO SKIN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>TO SKIN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>TO SKIN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566394-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863887-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDS NOT REPORTED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566395-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869283-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566396-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868973-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAMMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRICAL PETITE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>40/12.5</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566397-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201203002</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugdosagetext>500 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>78273</drugauthorizationnumb>
        <drugdosagetext>2 MG IV Q1 HOUR PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566398-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869437-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566399-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886445-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566400-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866835-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566401-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FOR A YEAR</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566402-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874696-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566403-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111018</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865722-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566404-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874726-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566405-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874325-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CAROTID ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566407-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867234-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566408-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869317-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566409-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888981-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566410-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867191-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566411-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885990-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUNGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>ON A SLIDING SCALE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566412-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888983-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566413-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566414-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889247-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY DAY AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566415-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867346-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566416-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566417-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887765-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20 MG EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566418-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867567-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN INITIAL DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566419-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864384-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566420-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888540-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>WEIGHT DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTE BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566421-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889251-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566422-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889244-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG EVERY HS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566423-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888805-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566424-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873767-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566425-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866782-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566426-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888982-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG X 2 TABLETS AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566427-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111013</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0863965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.198</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566428-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867116-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566429-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889243-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566430-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889007-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG ALTERNATING WITH 1000 MG QOD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COAG GARLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLACOMA DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566431-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867353-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG OXIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>IN THE TRILOGY STUDY EITHER TAKING PLAVIX OR EFFIENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>INJECTED SLIDING SCALE STARTING WITH 6U</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K+</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ERYTHEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>RASH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugdosagetext>IN THE TRILOGY STUDY EITHER TAKING PLAVIX OR EFFIENT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566432-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889245-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZEP HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO CU 10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AFTER LUNCH</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566433-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16993BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566434-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874023-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566435-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867148-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 AND 1000 MG</drugdosagetext>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566436-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888811-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566437-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16989BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUBDURAL HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566438-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867561-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.186</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXEPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566439-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889081-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566440-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889082-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566441-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874084-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AURICULAR SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566442-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867118-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APINDRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566443-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867227-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566444-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111022</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867115-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HORMONE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566445-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17022BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLIC STROKE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>108072</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>108072</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566446-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874839-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566448-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874775-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 EACH 1000MG DOSES TOGETHER ONCE A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566449-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873774-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566450-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566451-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874568-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRE-EXISTING CONDITION IMPROVED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566452-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874681-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JALYN</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566453-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867137-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566454-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868316-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566455-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867221-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING DRUNK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566456-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874865-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPOPROTEIN (A) ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566457-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES TWO 750MG TABLETS.</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES TWO 500MG TABLETS.</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>PER SLIDING SCALE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES THREE 500 MG TABLETS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566460-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845108-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EEMTHF ESTROGEN PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566461-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868974-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566462-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869440-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT LUNCHTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566463-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869434-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566464-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886471-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566465-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888969-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566466-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847703-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566467-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887749-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.394</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566468-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869454-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.848</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566469-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886513-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62.198</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566470-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888809-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566471-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110812</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>2 OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566472-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887709-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACID REFLUX PILL</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566473-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869367-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PLATELET AGGREGATION INHIBITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566474-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885447-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566475-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888859-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566476-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201203004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>78273</drugauthorizationnumb>
        <drugdosagetext>2 MG Q 2 HR (8 MG OVER 6 HRS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugdosagetext>10 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOTONIC SOLUTIONS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566477-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871095-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566478-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566479-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-062647</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>46</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090831</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE/VITAMIN D</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANIQA</medicinalproduct>
        <drugdosagetext>13.9%, TO CHIN AND UPPER LIP</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>HAIR GROWTH ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>1 PO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1000 MG Q6H (EVERY SIX HOURS) PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE/VITAMIN D</medicinalproduct>
        <drugdosagetext>2 BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>POWDER</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>FUNGAL INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100422</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566480-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847506-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566481-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-COVIDIEN/TYCO HEALTHCARE/MALLINCKRODT-T201203003</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>78273</drugauthorizationnumb>
        <drugdosagetext>2 MG IV AT 0100 AND 0200</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEBRIDEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROMORPHONE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>078273</drugauthorizationnumb>
        <drugdosagetext>1 MG IV EVERY 10 MINUTES</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566482-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871149-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566483-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887717-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RED RICE YEAST</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566484-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887828-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566485-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889010-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566486-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871106-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIET PILL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566487-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847472-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIURETIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566488-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888419-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566489-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889250-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>187.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566490-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566491-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871448-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERBAL SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566492-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847118-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG Q AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566493-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058916</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566494-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887850-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566495-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889078-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566496-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888572-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>WEEKLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO-BI-FLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566497-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869117-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>172.97</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPRAL XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO TAKING NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>STOPPED AFTER TAKING NIASPAN FOR 2 WEEKS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>MAXIMUM DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARPAL TUNNEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566498-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888576-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>1/2 TAB, TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566499-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866980-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566500-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMINICIN HCTZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566501-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111222</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566502-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869122-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566503-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888631-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELMIRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>FLUSHING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BIRTH CONTROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566504-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867166-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566505-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888979-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2-4MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>4X25 MG AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>5/20MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>ONCE EVERY AM AND PM</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>EVERY AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566506-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111223</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0886443-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566507-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888803-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566508-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869423-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566509-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888806-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566511-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885760-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566512-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566513-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889256-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>APOLIPOPROTEIN B INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566514-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888972-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGOMENORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>100 MG - AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566515-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566516-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864392-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566517-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111011</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864264-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>05021AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566518-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867145-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTALINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENIFIBER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566519-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867576-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566520-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16666BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566521-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111014</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0864746-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566522-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889024-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000MG DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566523-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867308-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566524-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865436-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566525-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874020-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566526-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111015</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865533-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566527-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16053BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566528-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865540-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111003</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566529-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866984-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566530-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111017</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0865302-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566531-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874773-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30-60 MINUTES PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566532-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868807-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566533-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846571-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DOSE: 1000</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110811</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566534-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888995-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566535-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889248-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566537-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874131-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566538-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874488-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566539-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868444-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FIRST DOSE TAKEN IN THE MORNING</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566540-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874085-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566541-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874565-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>37/25</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENESTERIDE</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugindication>INGROWING NAIL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566542-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874343-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID FACTOR POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566543-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867358-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566544-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874375-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566545-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868333-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.578</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>MK5171</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111006</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566546-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874532-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CARDIAC MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SEIZURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG Q HS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566547-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874872-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME FOLLOWING ASA</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566548-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867236-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566549-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868699-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>20 MINS BEFORE BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566550-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874836-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566551-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874080-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>2 BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTURA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYQUIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566552-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868691-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566553-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874506-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566554-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846531-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566555-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874734-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 - 45 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566556-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566557-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846643-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566558-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874583-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>160/25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>500/20MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>INTERRUPTED</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566559-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874543-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA EYE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOAT WHEY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AAZOR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566560-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846944-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110813</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566561-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874491-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566562-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566563-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847187-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>AT NIGHT TIME</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPTOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566564-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874731-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTI-ASTHMATICS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY HS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566565-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874327-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566566-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ENDO PHARMACEUTICALS INC.-PERC20120118</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>0</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugauthorizationnumb>040330</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566567-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847662-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566568-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874206-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566569-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-023504</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
        <drugtreatmentduration>407</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTIFOAM</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DRUG INEFFECTIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100422</drugenddate>
        <drugtreatmentduration>407</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566570-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566571-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847671-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.934</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENERGY DRINK SUPPLEMENT</medicinalproduct>
        <drugdosagetext>DRINK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566572-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874092-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111108</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566573-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG TAKEN AT BEDTIME.</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566574-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874730-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566575-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566576-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868969-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566578-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846621-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENACAR 40MG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566579-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869387-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60.382</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COLCRYS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD URIC ACID INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD URIC ACID INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566580-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PADAKA</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIRONE HCL</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIVIDOL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CHON</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN D DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566581-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887751-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>8.626</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566582-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111230</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0887754-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566583-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0888804-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.49</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>2 PILLS TWICE A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566584-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867127-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566585-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889084-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566586-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842876-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566589-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873937-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETIC MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566590-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868557-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>VENOUS OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566591-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874089-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566592-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874825-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.094</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FOR LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566593-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867583-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566594-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874317-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>4</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566595-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867181-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugbatchnumb>A020616A</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566596-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874338-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566597-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868440-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111016</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566598-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874887-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFEN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566599-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875292-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566600-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867250-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566601-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843005-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566602-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842960-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566603-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874891-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGIENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566604-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566605-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875287-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566606-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867595-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>EVERY OTHER DAY ALTERNATE WITH ZETIA</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566607-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843170-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEZOPHROIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566609-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110728</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566610-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867242-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566611-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875295-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566612-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867588-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111003</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566613-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566614-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842833-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566615-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566616-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867557-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566617-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875349-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ARTHRITIS MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D WITH CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOTOX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIDEPRESSANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566618-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867592-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566619-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843165-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110723</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566620-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842961-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHRITIS MEDICATION</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566621-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874081-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566622-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843085-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566623-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843172-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566624-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842708-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566625-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MILLIGRAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MILLIGRAM</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MILLIGRAM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566626-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874083-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH HER DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566627-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843043-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566628-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843167-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566629-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874840-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBIC</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566630-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843160-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566631-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842697-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTER C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE/MSM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METABOLIC THYROLEAN</medicinalproduct>
        <drugdosagetext>3 1/2 TABLETS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>DROP TO EYES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566632-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874927-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566633-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842959-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566634-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874566-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAZOSIN</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566635-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843028-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110730</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566636-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842692-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>5/325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50/25MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566637-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875278-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566638-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843145-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566639-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874405-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODITINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566640-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842964-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566641-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843002-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566642-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889772-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.376</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 IMES A DAY, 5 HOURS APART</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566643-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566644-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111115</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874504-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>OTC</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566645-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889305-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566646-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843166-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BIRTH CONTROL PILLS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566647-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889768-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120105</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566648-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875346-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHYPERTENSIVES</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566649-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0874873-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566650-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843023-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN + MSM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566651-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843012-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.376</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566652-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889662-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566653-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889771-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566654-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843171-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566655-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889770-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566656-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50912</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN FREQUENCY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566657-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890074-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>SLOWLY INCREASED, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566658-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889773-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566659-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889310-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566660-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843150-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>BLOOD MAGNESIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGULAR INSULIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEUROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugindication>NERVE INJURY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566661-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845817-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566662-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890055-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROXYPROGESTERONE</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566663-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890075-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566664-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111019</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0866866-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566665-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINE COLOUR ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566666-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867196-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566667-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873757-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566668-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0873771-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566669-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867734-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566670-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867732-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566671-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867857-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566672-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845705-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566673-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889531-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566674-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845831-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566675-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867854-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566676-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867765-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566677-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890473-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566678-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867753-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>MYALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566679-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846403-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566680-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867923-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566681-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846221-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>POLYCOSINOL OTC</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIT E NATURAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FISH OIL KRILL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566682-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845825-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566683-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846145-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566684-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867887-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.474</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DOSE INCREASED AGAIN</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111018</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INCREASED 1000 MG TO 2000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INCREASING DOSE FROM 1000 MG TO 2000 MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AE LEAD TO REDUCTION BACK TO 1000 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAPERING FROM 500 MG TO 1000 MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566685-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867869-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITNOVITE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111011</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566686-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867646-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566687-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890464-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPAEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT (PREVIOUSLY ON 500MG)</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566688-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867608-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.702</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>WHEN TAKING NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566689-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG DOSE IN MORNING AND AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566690-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-BRISTOL-MYERS SQUIBB COMPANY-16688756</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERAX</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVOTRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITALUX</medicinalproduct>
        <drugdosagetext>1DF=4 TABS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugindication>CHRONIC MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101025</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566691-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869678-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566692-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566693-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846420-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566694-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566695-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869819-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTI INFLAMMATORY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566696-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869679-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TECOSIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111024</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>CARDIAC FAILURE CONGESTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566697-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867848-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566698-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869815-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugdosagetext>5/20 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566699-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869497-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566700-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867885-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTH</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566701-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890478-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOMBIGLYZC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566702-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847921-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566703-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867862-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>PILL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566704-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869859-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145.28</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566705-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-BRISTOL-MYERS SQUIBB COMPANY-16824401</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>FIRST COURSE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566706-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845979-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566707-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847869-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNREPORTED DOSE AT HS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566708-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869814-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566709-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846182-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566710-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847929-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566711-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800267</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARACHNOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>7-8 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566712-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120609040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.25</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>CBS13014P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLITIS ULCERATIVE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE / CHONDROITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>CBS13014P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>CBS13014P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>CBS13014P1</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566713-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800955</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566714-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800977</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOSPITALISATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVEGA SUSTENNA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022264</drugauthorizationnumb>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566715-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869476-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.296</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCCUVITE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566716-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867859-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUANIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAPERING TO 1000 MG FOR ONE YEAR</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LODINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARISOPRODAL OR FLEXORIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCTE N</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIDEPRESSANTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566717-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847963-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566718-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-BRISTOL-MYERS SQUIBB COMPANY-16820722</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>YERVOY</medicinalproduct>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566719-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566720-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869665-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>119.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566721-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022224</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566722-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVALO</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566723-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869493-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566724-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869494-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566725-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869535-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566726-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848094-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>OTC/ AT BEDTIME</drugdosagetext>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566727-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869850-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566728-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870076-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566729-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869499-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS SOLOSTAR</medicinalproduct>
        <drugdosagetext>PEN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566730-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOD POISONING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566731-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013044</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>2XF548</drugbatchnumb>
        <drugauthorizationnumb>021249</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EYE SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>021249</drugauthorizationnumb>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566732-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848089-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO-Q-10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566733-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870043-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566734-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870135-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG ER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566735-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010323</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
        <drugtreatmentduration>2897</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
        <drugtreatmentduration>2897</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566736-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP058950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHIAL HYPERREACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBESITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS VIRAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091228</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566737-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA013062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugauthorizationnumb>019658</drugauthorizationnumb>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugbatchnumb>2GPKA2</drugbatchnumb>
        <drugauthorizationnumb>019658</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566738-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869783-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>ANGINA PECTORIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOFIDRATE</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOFIDRATE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE XR</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566739-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP025819</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURAX-H</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012): DOSGE: 50GRAMS PER DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012): DOSAGE: DAILY DOSE UNKNOWN, AS NEEDED</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID (SENNA)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugdosagetext>25MG/DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOGMATYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.78MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120418</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
        <drugtreatmentduration>28</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONA</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>RASH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERISONA</medicinalproduct>
        <drugdosagetext>50G/DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012): FORMULATION: EXT</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120422</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTIVIRAL (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISODINE</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>051</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASMOTIN</medicinalproduct>
        <drugdosagetext>UPDATE (02JUL2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LENDORMIN D</medicinalproduct>
        <drugdosagetext>0.25MG/DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EURAX-H</medicinalproduct>
        <drugdosagetext>50G/DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
        <drugtreatmentduration>45</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG/DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PYREXIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120420</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566740-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870144-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566741-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845830-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566742-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867598-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111017</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566743-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120103</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889999-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS AT NIGHT, 1000MG</drugdosagetext>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JALYN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566744-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889769-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566745-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890077-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120102</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566746-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890484-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566747-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889306-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566748-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845821-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566749-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845818-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES AFTER DOSE OF NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566750-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845707-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ONCE IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566751-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845815-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER LUNCH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566752-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0842888-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566753-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566754-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845824-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>VARYING DOSES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566755-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889733-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BP MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566756-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566757-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867805-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566758-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890080-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566759-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889766-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIMOPTIC EYE DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566760-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110813</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846034-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATOCHEZIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN (COATED) DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN (COATED) DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566761-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845715-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566762-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845711-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566763-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845801-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566764-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845783-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>138.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG 5 DAYS PER WEEK, AND 10MG 2 DAYS A WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566765-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846406-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566766-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845721-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566767-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889638-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566768-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845848-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566769-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867690-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>EVERY AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566770-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890485-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566771-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889664-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566772-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845954-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566773-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867712-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566774-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110815</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0846049-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHAGAN P</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566775-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890476-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566776-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889425-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566777-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111024</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867807-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADISTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566778-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869735-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>MONDAYS, WEDNESDAYS, + FRIDAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENESTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566779-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845784-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL TENESMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566780-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869861-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG AT BEDTIME</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566781-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869656-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566782-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867864-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICIATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566783-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870041-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEFIDICAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566784-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869461-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566785-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120711422</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566786-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120702522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE INTRACRANIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566787-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120706416</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566788-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120801175</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>COLONOSCOPY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566789-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120709484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566790-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870039-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111030</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566791-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869457-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>132.11</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIURETIC MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566792-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110817</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848076-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT LEAST 30 MIN BEFORE NIASPAN DOSE</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566793-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP015285</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugbatchnumb>385355</drugbatchnumb>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566794-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847928-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG IN THE MORNING, 500MG AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566795-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120105</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889767-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566796-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845811-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566797-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845847-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566798-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845808-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 CRILL OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566799-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE REPLACEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIO VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566800-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110812</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0845826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566801-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0889660-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566802-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111027</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869795-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>AUTOIMMUNE THYROIDITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566803-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870345-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566804-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869957-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIATA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566805-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870394-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566806-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879629-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>WITH EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIMETIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566807-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076983</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566808-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076908</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566809-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-BAYER-2012-076297</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG-INDUCED LIVER INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS FULMINANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLETAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugauthorizationnumb>021317</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566810-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847876-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566811-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847844-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566812-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111030</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870342-00</companynumb>
    <primarysource>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566813-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879654-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>WITH EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITALIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566814-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847914-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566815-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870429-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566816-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879975-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566817-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848041-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D-3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVALOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566818-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879413-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566819-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879741-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT QUALITY ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCT COLOUR ISSUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566820-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAL WITH D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566821-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847931-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566822-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879858-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVERAL BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETES MEDICATION</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566823-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566824-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566825-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879893-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566826-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848113-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566827-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843819-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566828-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843807-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NGIHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566829-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844088-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566830-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843817-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566831-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848190-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN NASAL SPRAY</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110818</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566832-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870324-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566833-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879539-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566834-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870449-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.204</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566835-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844110-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>EXTRA STRENGTH TYLENOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110803</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566836-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844090-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145.28</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESACER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110728</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566837-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870180-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ASTHMA INHAHER</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566838-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879798-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566839-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843926-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566840-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844200-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566841-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870191-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566842-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852422-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACID REDUCER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566843-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879727-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566844-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852248-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INCREASED DOSE</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566845-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843891-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPLETE LIST NOT REPORTED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566846-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879656-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566847-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852245-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566848-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843811-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566849-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852410-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566850-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852027-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEFORMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566851-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852492-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566852-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843738-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110725</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566853-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879728-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETIC MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566854-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844094-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADISTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>2.5/500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566855-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852449-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugdosagetext>MSN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPPLEMENT 50+ GMC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566856-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566857-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566858-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843890-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566859-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844128-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566860-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852457-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566861-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852193-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566862-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843812-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566863-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843923-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D 5000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566864-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852496-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENNA-MINT WAF</medicinalproduct>
        <drugindication>PHYTOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566865-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE HCT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566866-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852026-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KRILL OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110906</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566867-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566868-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879967-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.05</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN INHALER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STERIOD MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566869-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852032-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566870-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870068-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566871-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847886-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN GASTRITIS PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566872-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869944-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566873-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869942-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111026</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566874-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.06</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG X 2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROQUICK</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566875-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847910-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566876-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870329-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566877-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869964-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE TAKING NIASPAN AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566878-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848046-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETES MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566879-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870094-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116.68</patientweight>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566880-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847873-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPATIENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PALPITATIONS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110827</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566881-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-UCBSA-062864</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugauthorizationnumb>022064</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATOPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566882-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870038-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG AT BEDTIME (3RD WEEK)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME (1ST WEEK)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG AT BEDTIME (2ND WEEK)</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566883-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110816</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848070-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566884-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870298-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566885-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879409-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566886-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566887-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869830-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566888-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111028</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566889-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566890-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077639</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566891-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-076665</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566892-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077742</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALEVE (CAPLET)</medicinalproduct>
        <drugauthorizationnumb>020204</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566893-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-BAYER-2012-077115</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugauthorizationnumb>019537</drugauthorizationnumb>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EPIDIDYMITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120326</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566894-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870185-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HYPERTENSION MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566895-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847925-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.702</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566896-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870498-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.462</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566897-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879410-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>1 HOUR PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566898-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110818</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0847888-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG AT HS</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566899-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843818-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566900-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879971-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566901-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848096-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110820</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566902-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848063-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULORIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLTRYS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BABY VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>BEFORE MEALS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566903-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52985</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566904-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879738-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STAZOR</medicinalproduct>
        <drugindication>ANTIDEPRESSANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEODON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566905-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-UCBSA-060449</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>24</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICS</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 UNIT, TAKE BY MOUTH DAILY</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>TAKE 20 MG BY MOUTH DAILY</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRAM</medicinalproduct>
        <drugdosagetext>50 MG, 1 TABLET BY MOUTH EVERY 6 HOURS AS NEEDED FOR 20 DAYS</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110329</drugenddate>
        <drugtreatmentduration>106</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500-0.74MG/100 ML-%, INJECT 100 MLS INTO THE VEIN EVERY 8 HOURS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugdosagetext>500 MG, TAKE 1 TABLET BY MOUTH 2 TIMES DAILY FOR 11 DAYS</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500 MG, TAKE 1 TABLET BY MOUTH 3 TIMES DAILY FOR 11 DAYS</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DELTASONE</medicinalproduct>
        <drugdosagetext>10 MG TABLET</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIMZIA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101019</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566906-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848020-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566907-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870338-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566908-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG, DAILY</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BICTOZA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566909-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848093-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566910-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111129</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879520-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566911-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>BLOOD PRESSURE MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>RENIN-ANGIOTENSIN SYSTEM INHIBITION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566912-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843924-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1/2 HR PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566913-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879464-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566914-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843825-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566915-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110819</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0848160-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566916-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0879692-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAPULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566917-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843894-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566918-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870439-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566919-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852149-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566920-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111031</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0869812-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING FOLLOWING ASA</drugdosagetext>
        <drugindication>LIPOPROTEIN (A) ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566921-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852516-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566922-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843866-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566923-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566924-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843893-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566925-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852829-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566926-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852504-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145.28</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566927-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859763-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566928-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566929-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852478-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566930-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860087-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110926</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566931-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843897-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566932-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110927</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859285-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566933-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852958-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566934-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852487-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566935-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859604-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566936-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860111-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugdosagetext>COMPLETE WAS LIST NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETIC MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566937-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852975-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566938-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844092-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.204</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN COATED</drugdosagetext>
        <drugindication>ADVERSE EVENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566939-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>PATCH, 8 HOURS PER DAY, AT NIGHT</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>IN THE MORNING, ONCE WEEKLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566940-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859931-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566941-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566942-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859981-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH HIS DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>019304</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566943-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566944-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859756-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARTIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566945-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852257-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAINFUL RESPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566946-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860353-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090915</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566947-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860509-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566948-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860047-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566949-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859929-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566950-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566951-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860647-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566952-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859926-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG - AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566953-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860771-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566954-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859928-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566955-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860483-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566956-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861100-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116.68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566957-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861005-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>57.658</patientweight>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566958-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853133-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOTOPROL</medicinalproduct>
        <drugindication>HEART RATE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566959-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852970-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566960-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKING WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566961-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566962-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111002</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859933-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566963-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884374-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566964-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860597-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566965-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859752-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566966-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BRIMONIDINE 0.2 OP SOL</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLU VACCINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110921</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566967-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566968-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>HAS BEEN TAKING FOR 2 MONTHS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DISCONTINUED, THEN RESTARTED JUL 2011</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOUT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566969-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860511-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COULD NOT RECALL NAMES OF REMAINING MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566970-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884776-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566971-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859925-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566972-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853822-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566973-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.364</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZZA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566974-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884717-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566975-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860722-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566976-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885193-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111130</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566977-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884177-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>163.44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566978-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853444-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.1</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566979-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884630-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566980-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110911</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853285-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566981-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860762-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT HS BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566982-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853277-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MIN PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566983-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884158-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111217</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566984-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860847-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566985-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50517</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566986-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884377-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.254</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566987-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880016-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566988-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853509-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566989-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885136-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566990-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884180-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566991-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>92</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566992-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853165-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL MORPHOLOGY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOPHOBIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566993-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861124-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111004</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABANTIN</medicinalproduct>
        <drugindication>NEURALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566994-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853497-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566996-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852238-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>WEIGHT DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugdosagetext>PEN INJECTION</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566997-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852541-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566998-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852954-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110909</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8566999-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111102</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0870496-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567000-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852426-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567001-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852773-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO NIASPAN DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567002-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859370-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSEQUIN DS</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567003-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567004-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843937-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567005-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859491-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567006-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852025-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567007-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859927-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567008-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859831-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETIC PILL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567009-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852961-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>POSSIBLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567010-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859998-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTRA-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567011-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852055-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567012-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860347-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567013-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859773-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FOR ONE MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TWO AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567014-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860101-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT EXHAUSTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TEMPERATURE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567015-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860477-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567016-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853130-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567017-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852694-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.278</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567018-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110928</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859422-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567019-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860475-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567020-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111001</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567021-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860031-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC OTC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567022-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852396-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567023-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861091-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567025-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111006</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860589-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567026-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110929</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0859466-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567027-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0852965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPHEDRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567028-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860724-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567029-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884171-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111210</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567030-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860781-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFALTREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLTX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567031-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884167-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567032-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884337-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567033-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0861104-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>AORTIC OCCLUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567034-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884878-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567035-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884165-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567036-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111004</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567037-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116.22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTHER DRUGS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567038-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567039-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111005</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860846-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATRIPLA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567040-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853155-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567041-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884962-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>OVER-THE-COUNTER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567042-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853345-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>500/20 MG EVERY HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>UNREPORTED IU DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567043-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111003</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0860646-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567044-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880257-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567045-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880859-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY WITH LUNCH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY WITH LUNCH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567046-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875351-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.524</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/25MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1 TAB = 1 GM; TWO TABLETS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567047-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880867-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCTZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCETRIZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567048-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850185-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE TAB 500MG</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS 500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE 750 MG TAB</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE TAB 500 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567049-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>ASTHENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111129</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>ABDOMINAL PAIN UPPER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567050-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875933-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567051-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880854-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567052-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110827</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850021-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL ME</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567053-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881225-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.124</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORACEA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567054-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849987-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DALMANE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567055-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567058-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850155-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110820</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE CR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567059-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567060-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849431-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567061-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567062-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881068-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567063-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110907</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567064-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875600-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLA FRUIT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYSINE PROPYNOL L-CARNITINE HCI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUICE PLUS VINEYARD BLEND</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KRILL OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACAI BERRY</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111107</drugstartdate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>DENTAL DISORDER PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SLO-MAG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGHLY ACTIVE TART CHERRY</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUICE PLUS GARDEN BLEND</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UBIQUINOL COQ10</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER STRESS B COMPLEX WITH VITAMIN C</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARGININE AKG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUICE PLUS ORCHARD BLEND</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARNITINE</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ARTHRITIS</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GREEN SELECT</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>SCIATICA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRUIT FLOW</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567065-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880549-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567066-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875780-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORADOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOPRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567067-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850386-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567068-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880551-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRINDALAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567069-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881085-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HTCZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IDORAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567070-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849492-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567071-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881200-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS C AND D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567072-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567073-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875790-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567079-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567080-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885000-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567081-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853264-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>PEN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567082-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880861-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567083-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880478-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVERAL OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022224</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567084-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853274-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110905</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567085-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567086-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853254-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>TWICE A WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FORMULATION OF LAMISIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>OTC</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567087-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880850-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBULIZER TREATMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567088-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880602-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVIGEL</medicinalproduct>
        <drugindication>NARCOLEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHERATUSSIN</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYCOPYRROLATE</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTALINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZANIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETERON</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZANIDINE</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZTIA XT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567089-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853141-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
        <drugtreatmentduration>27</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567090-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884595-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.032</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY VITAMIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER OIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORTICAL</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>BONE DENSITY DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A + D</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567091-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880128-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567092-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881193-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567093-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881060-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG TO 1500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOAVAN/HCTZ</medicinalproduct>
        <drugdosagetext>160/25 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567094-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853580-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567095-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884599-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>RESTARTED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>STOPPED FOR 2-3 WEEKS, THEN RESTARTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567096-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880115-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYLIN</medicinalproduct>
        <drugindication>DECREASED APPETITE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STARLIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567097-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881071-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567098-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880099-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567099-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884582-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITREX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567100-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880113-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567101-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844207-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AT AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYVANSA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567102-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881194-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567103-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880452-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567104-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRUCEL</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567105-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880117-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OVER 50 VITAMIN PACK</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567106-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844239-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567108-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881189-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567109-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880548-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DPT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INFLUENZA VACCINE</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>IMMUNISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>BLADDER DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567110-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PENIS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugauthorizationnumb>020788</drugauthorizationnumb>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ALOPECIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567111-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP023351</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugdosagetext>180 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VICTRELIS</medicinalproduct>
        <drugauthorizationnumb>202258</drugauthorizationnumb>
        <drugdosagetext>200 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567112-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0885003-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567113-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880392-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567114-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1108USA01234</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KYPHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>X-RAY ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKELETAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCAPULA FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNAMBULISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MK-9278</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>500 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090109</drugenddate>
        <drugtreatmentduration>335</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090301</drugenddate>
        <drugtreatmentduration>51</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19961001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090531</drugenddate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090718</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070905</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080220</drugenddate>
        <drugtreatmentduration>169</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>3000 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19940101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567115-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844211-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567116-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881220-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567117-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880725-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567118-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110910</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853281-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>15-30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567119-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849477-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG, AT HS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVE WELL JOINT SUPPLEMENT</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>AORTIC VALVE REPLACEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567120-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880270-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE DAYTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567121-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844214-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567122-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880767-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FOR TWO DOSES ONLY THEN DECREASED</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567123-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854130-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567124-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849438-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM LA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567125-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880453-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567126-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849412-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567127-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881059-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567128-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853269-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567129-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849520-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG DAILY</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567130-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880536-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567131-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849665-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HTCZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567132-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567133-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849809-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567134-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880017-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEVERAL UNKNOWN MEDICATIONS</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567135-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880472-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567136-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849820-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUCRALFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567137-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881216-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567138-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849483-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567139-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880144-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567140-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880606-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567141-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881072-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121.22</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKA SELTZER</medicinalproduct>
        <drugdosagetext>WITH NIASPAN</drugdosagetext>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567142-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849554-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567143-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849972-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NO THERAPEUTIC RESPONSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567144-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880434-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.364</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567145-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880640-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG DAILY</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>STRESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>STRESS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567146-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880847-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111204</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567147-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567148-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849692-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MILLIGRAM, DAILY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567150-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880436-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NGT</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567151-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880433-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PSYLLUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567152-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881165-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567153-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850160-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACID PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567154-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110822</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849804-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>04176AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>04176AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567157-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110908</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853166-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567158-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567159-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880255-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BREAKFAST AND EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BREAKFAST AND EVENING MEAL</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567160-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884279-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567161-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853728-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>EYE</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>NEPHROLITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>BLOOD URIC ACID INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567162-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567163-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880451-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567164-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884635-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567165-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884368-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567166-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853271-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567167-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880884-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111203</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567168-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880498-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567169-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853712-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE D</medicinalproduct>
        <drugindication>BONE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567170-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0884777-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMIRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567171-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0853476-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567172-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880862-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567173-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880463-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567174-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880513-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567175-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849391-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567176-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854716-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567177-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850006-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110828</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567178-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844282-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL HYDROCHLORTHIAZID</medicinalproduct>
        <drugdosagetext>50/12/5</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVA THYROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
        <drugdosagetext>PILLS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567179-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.296</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME/DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567180-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854744-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110815</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JAYLN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567181-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855357-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 TABS AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567182-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849489-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567183-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875941-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567184-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854910-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567185-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850181-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.364</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567186-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881274-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567187-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE DOSE, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE DOSE, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567188-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>100/25MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567189-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854685-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567190-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881511-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME WITH NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567191-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844300-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567192-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875784-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567194-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854896-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.254</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567195-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850172-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110823</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110829</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567196-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844286-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567197-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0634669-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100317</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100312</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110513</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100317</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>BLOOD CALCIUM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>MITRAL VALVE PROLAPSE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567198-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855021-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567199-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875605-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567200-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844460-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110707</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567201-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876064-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111107</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTIM</medicinalproduct>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567202-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881971-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567203-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855009-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567204-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>31</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES 4 AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567205-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567206-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875771-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567207-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT LUNCHTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567208-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881272-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567209-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567210-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844410-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567211-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850372-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MANY OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567212-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881534-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567213-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855378-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567214-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875918-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVSIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567215-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3MG X 3 DAYS A WEEK AND 5MG X 2 DAYS A WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567216-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875581-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567217-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881501-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567218-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HTCTZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CETRIRIZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTAXANTHIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567219-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875774-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG IN AM, 500MG IN PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111119</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567220-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854296-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567221-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844404-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022224</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567222-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881271-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567223-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875762-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567224-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567225-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854429-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567226-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844461-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567227-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871689-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugdosagetext>30 MIN BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567230-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567231-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854742-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT 3D 4000</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMARA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM 600 MG + VIT D 400 MG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567232-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875766-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIVASTIGMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>200/25</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANCXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>PATCH IN THE MORNING AND OFF AT NIGHT</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567233-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110824</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849446-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567234-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567235-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850177-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567236-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ILL-DEFINED DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567237-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844412-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567238-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849503-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>64.014</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL PLUS D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENELOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567239-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850368-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 PO AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567240-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567241-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844406-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110806</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567242-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854733-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULERA INHALER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567243-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>EYE DROP</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567244-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850502-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567246-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850150-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567247-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854240-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567248-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854941-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRIGGER FINGER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567249-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850047-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567250-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875617-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMADRINE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>06151AS</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IBUPROFEN TABLETS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>60 MINUTES BEFORE TAKING NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>ROUTINE HEALTH MAINTENANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567251-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849743-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567252-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMIG</medicinalproduct>
        <drugauthorizationnumb>020768</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567253-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854420-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110910</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567254-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855195-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567255-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849824-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567256-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876274-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG IN MORNING, 500MG IN EVENING</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>2 TO 3 TIMES DAILY AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567257-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849998-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>100MG/40MG AT HOUR OF SLEEP DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567258-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854729-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BETA BLOCKER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567259-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855351-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110910</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567260-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875910-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567261-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849499-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110819</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567262-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855201-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567263-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849977-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567264-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012MX065926</companynumb>
    <primarysource>
      <reportercountry>MEXICO</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHOLESTEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MG, 2 EVERY 24 HOURS</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>GASTRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, QD TWO DOSE</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
        <drugdosagetext>100 MG, 2 EVERY 24 HOURS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG, 1 EVERY 24 HOURS</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugdosagetext>4 SHOTS</drugdosagetext>
        <drugindication>ANTASTHMATIC DRUG LEVEL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG  THREE DOSE</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugdosagetext>300 UG, QD ONE APPLICATION 1 EVERY 24 HOURS</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
        <drugdosagetext>500 MG, 2 SHOTS</drugdosagetext>
        <drugindication>ANTASTHMATIC DRUG LEVEL THERAPEUTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567265-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP066448</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugdosagetext>150 UG, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
        <drugtreatmentduration>260</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567266-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US013375</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567267-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016325</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugauthorizationnumb>020802</drugauthorizationnumb>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567268-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA056212</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567269-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567270-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016728</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CRUSH INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GUN SHOT WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugdosagetext>2 TO 3 DF, PRN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19670101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567271-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US009917</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNDERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SJOGREN'S SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>10100872</drugbatchnumb>
        <drugdosagetext>1 DF, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXCEDRIN EXTRA STRENGTH TABLETS</medicinalproduct>
        <drugbatchnumb>10100872</drugbatchnumb>
        <drugdosagetext>2 DF AT A TIME FOR A TOTAL OF 4-6 QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567272-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012PL038683</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567273-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US015509</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>LUNG INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19790418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19790418</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA                                 /USA/</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>GASTRIC ULCER HAEMORRHAGE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAALOX ANTACID/ANTIGAS RS LIQ COOL MINT</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>GASTRIC ULCER HAEMORRHAGE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567274-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FI062329</companynumb>
    <primarysource>
      <reportercountry>FINLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY MASS INDEX INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE HCL</medicinalproduct>
        <drugdosagetext>400 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>500 MG, PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567275-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850399-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110825</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567276-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850384-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567277-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855019-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>6.25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 IU</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567278-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844413-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567279-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875362-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCHICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567280-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871644-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567281-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110807</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844403-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567284-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875866-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111120</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567285-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844411-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567286-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881242-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567287-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849401-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567288-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850029-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.68</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugdosagetext>EYE DROPS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40MG IN AM AND 40MG IN PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110829</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>240MG IN AM + 240MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONILACTONE</medicinalproduct>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567289-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850166-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110822</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG USED IN DIABETES</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567290-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854249-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567291-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880821-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567292-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849384-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE IN THE MORNING, ONCE AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100825</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugdosagetext>OVER THE COUNTER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567293-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849505-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060826</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567295-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875867-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567296-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854407-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATANCAND HCT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567297-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880823-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567298-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849423-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110822</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONTRACEPTIVES</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567299-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110812</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugdosagetext>320/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567300-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110805</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844266-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110804</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567301-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854614-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567302-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0880789-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>FAMILIAL TREMOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugindication>CYTOGENETIC ABNORMALITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567303-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110825</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849385-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.566</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSAMINE DS</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567304-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850154-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567305-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0875937-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567306-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854889-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567307-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843177-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMETHACIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567308-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850024-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TITRATED UP FROM 500MG DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567309-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850176-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN 24 HR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN MG STRENGTH, BID</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567310-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844392-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567311-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854604-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZAPEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567312-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849425-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567313-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110826</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849506-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.426</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>40 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567314-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881944-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567315-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567316-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854947-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567317-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854974-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110910</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110911</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567318-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881972-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567319-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856645-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567320-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855017-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567321-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2011US12272</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ANTRAL VASCULAR ECTASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>021560</drugauthorizationnumb>
        <drugdosagetext>1.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110712</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>15 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110713</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALCYTE</medicinalproduct>
        <drugdosagetext>450 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON DEXTRAN</medicinalproduct>
        <drugdosagetext>1000 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON DEXTRAN</medicinalproduct>
        <drugdosagetext>1025 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>021560</drugauthorizationnumb>
        <drugdosagetext>0.75 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110725</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110829</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON DEXTRAN</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>2 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>1000 MG, BID</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>URINARY TRACT INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110828</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110830</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567322-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567323-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015109</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567324-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004080</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIFFERENTIAL WHITE BLOOD CELL COUNT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>4036</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567325-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015015</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIGAMENT RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0019</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567326-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012SE011018</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSIDE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567327-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR066697</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GROIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG/100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, / 100ML</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567328-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010GB04645</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>H1N1 INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEUPOGEN</medicinalproduct>
        <drugindication>NEUTROPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugdosagetext>2 DF, UNK</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYOSCINE HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>300 UG/DAY</drugdosagetext>
        <drugindication>SALIVARY HYPERSECRETION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>300MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>400 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>250 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567329-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US010655</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FURUNCLE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0013A</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>405</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567330-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR066657</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugauthorizationnumb>021283</drugauthorizationnumb>
        <drugdosagetext>ONE TABLET DAILY (160 MG)</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567331-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855020-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567332-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856356-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.702</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME FOR 1 DOSE</drugdosagetext>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567333-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US07564</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC ANEURYSM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED INTEREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLASMACYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALIGNANT MELANOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COLUMN STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL ABRASION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AXILLARY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPHYSEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20011106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THALIDOMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20041013</drugenddate>
        <drugtreatmentduration>1073</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567335-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN061664</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>34</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugauthorizationnumb>019851</drugauthorizationnumb>
        <drugdosagetext>2 DF, A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugauthorizationnumb>019851</drugauthorizationnumb>
        <drugdosagetext>1 DF, A DAY</drugdosagetext>
        <drugindication>GESTATIONAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugauthorizationnumb>019851</drugauthorizationnumb>
        <drugdosagetext>1.5 DF A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOTENSIN</medicinalproduct>
        <drugauthorizationnumb>019851</drugauthorizationnumb>
        <drugdosagetext>1 DF A DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567336-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012KR065964</companynumb>
    <primarysource>
      <reportercountry>KOREA, REPUBLIC OF</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD UREA INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
        <drugtreatmentduration>145</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120527</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567337-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012553</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATE CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTATIC NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>458</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567338-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2009US03631</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROGENIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMAUROSIS FUGAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MARROW HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTINIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRIMARY SEQUESTRUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCLONAL GAMMOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BICYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BENIGN PROSTATIC HYPERPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL SYMPTOM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCHOLESTEROLAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANHEDONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPLENOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERURICAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEBORRHOEIC KERATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BUNDLE BRANCH BLOCK RIGHT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE HEART DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCIUM METABOLISM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL OSTEODYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIDIDYMITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHERMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAW FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL RECESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL NEOPLASM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>500 MG, QMO</drugdosagetext>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEMADEX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOCORT EC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEPHROCAPS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugdosagetext>6000 U, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DARVOCET-N 50</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAPTOMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLAZONE</medicinalproduct>
        <drugdosagetext>5 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEMPLAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG, QHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 DF, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567339-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA012410</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROENDOCRINE CARCINOMA METASTATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DUODENAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>5-HYDROXYINDOLACETIC ACID IN URINE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>30 MG, EVERY 4 WEEKS</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>CARCINOID TUMOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567340-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855442-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTOID REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROAT TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>95577AF21</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE MONTH OF OFFICE SAMPLES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>95577AF21</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FILLED PRESCIPTION - TOOK ONE DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>95577AF21</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567341-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855372-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567342-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881630-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567343-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882300-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIP DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/20</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567344-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882290-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111206</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BARRETT'S OESOPHAGUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567345-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855367-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567346-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855741-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567347-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882164-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567348-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881963-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR BEFORE NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567349-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882077-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULCOLAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1XNITE</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA RED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONCE-A-DAY WOMEN'S FORMULA VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINKO BILO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567350-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855665-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567351-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881982-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567352-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567355-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065892</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL ACUITY REDUCED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>10093131</drugbatchnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567356-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882308-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EYELID OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIRTRALINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567357-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP064045</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SYSTEMIC LUPUS ERYTHEMATOSUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VOLTAREN-XR</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, DAILY</drugdosagetext>
        <drugindication>PROCEDURAL PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567358-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015153</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.388</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASTICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT SPASTIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLUMSINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLUGGISHNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567359-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012GB010384</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BODY MASS INDEX DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN CELL VOLUME DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MONOCYTE COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050519</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>250 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>UNK DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060713</drugenddate>
        <drugtreatmentduration>38</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LACTULOSE</medicinalproduct>
        <drugdosagetext>10 ML, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRIMETHOPRIM</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENDROFLUAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567360-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004037</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN I INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE PHOSPHATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugauthorizationnumb>019201</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567361-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CN060461</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>39</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMA HEPATIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOGLOBIN BLOOD INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEBIVO</medicinalproduct>
        <drugauthorizationnumb>22011</drugauthorizationnumb>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120712</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567362-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2010EE10851</companynumb>
    <primarysource>
      <reportercountry>ESTONIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONCOMITANT DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
        <drugdosagetext>120 MG, X 1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLU-MEDROL</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3-9 MG ACCORDING TO INR</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIORAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED ALISKIREN</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDOPAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>DYSLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, X 1</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED</medicinalproduct>
        <drugdosagetext>CODE NOT BROKEN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIGRAN</medicinalproduct>
        <drugindication>RENAL FAILURE CHRONIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugdosagetext>850 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110105</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567363-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US011159</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567364-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015161</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENZYME LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567365-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU061699</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS INFECTED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SERETIDE</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567366-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US00484</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOOSE TOOTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL FIBROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULPITIS DENTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROTATOR CUFF SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOITRE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMEGALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EUSTACHIAN TUBE PATULOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMANGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLAVICLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECCHYMOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DYSTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HILAR LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARACHNOID CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR SPINAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENCEPHALOMALACIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO LYMPH NODES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC SPACE NARROWING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPONDYLOLISTHESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL NERVE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL POLYP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC TAMPONADE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLLAGEN-VASCULAR DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOCAL CORD ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>10 MG, QW</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>0.5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG,</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567368-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMOLOG INSULIN</medicinalproduct>
        <drugdosagetext>UP TO 4 TIMES A DAY ACCORDING TO SLIDING SCALE</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETELOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567369-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854708-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN EYE DROP MEDICATION</medicinalproduct>
        <drugdosagetext>EYE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HIGH BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567370-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881835-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>AT NOON</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567371-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854818-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>10/650MG</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567372-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854939-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE HOUR BEFORE BEDTIME</drugdosagetext>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110906</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567373-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856151-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567374-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881589-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567375-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015025</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLOUR BLINDNESS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567376-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012JP059958</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIVADIL</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL ANTIDIABETICS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>150 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>188</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567377-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US014805</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567378-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US00467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESBYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HUMERUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXPOSED BONE IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BARTHOLIN'S CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHORIORETINAL ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITREOUS DETACHMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENORRHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORDEOLUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINAL DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTIGMATISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPIRATION BONE MARROW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHYSICAL DISABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER LIMB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567379-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015112</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567380-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015148</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567381-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066845</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567382-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015103</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISSURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567383-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2010JP82178</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>C-REACTIVE PROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERPHENAZINE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEROSPIRONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100818</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100820</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>175 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100815</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100817</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNIDE</medicinalproduct>
        <drugdosagetext>12 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXOTAN</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKENE</medicinalproduct>
        <drugdosagetext>400 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100730</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMPERIDOL</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100814</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALMARL</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>1500 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100729</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100802</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100804</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100806</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100910</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100914</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100807</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100808</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMIPERONE</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>24 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLONANSERIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOMEPROMAZINE MALEATE</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>3 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>125 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100811</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100812</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100814</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AKINETON</medicinalproduct>
        <drugdosagetext>4 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEILAX</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILECE</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567385-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US012548</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567386-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012SE011018</companynumb>
    <primarysource>
      <reportercountry>SWEDEN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>8 MG, QD</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160 MG, QD</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19910101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSIDE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ILARIS</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567387-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882024-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILT-CD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>40/12.5</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567388-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871968-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567389-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855046-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567390-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882173-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111211</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567391-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881595-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 /500MG TABS; 3 TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567392-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855363-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICLOFENAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567393-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882213-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567394-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855204-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567395-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-08P-163-0482054-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567396-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881450-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567397-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-03P-163-0387698-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BETA BLOCKER</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567398-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567399-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567400-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855837-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567402-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110830</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850382-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2 PO AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>325 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200 MILLIIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567403-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US065886</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>86</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567404-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854425-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567405-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854618-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567406-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011CA53531</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FUNGAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINEA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG/ DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120726</drugenddate>
        <drugtreatmentduration>424</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567407-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NZ064606</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULAR FILTRATION RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEAN PLATELET VOLUME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021022</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>287.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>162.5 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMISULPRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>750 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>AFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567408-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US011850</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567409-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012JP002544</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100303</drugenddate>
        <drugtreatmentduration>56</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110821</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
        <drugtreatmentduration>701</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120202</drugenddate>
        <drugtreatmentduration>701</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111021</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110818</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SLOW-K</medicinalproduct>
        <drugdosagetext>600 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOKALAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3.25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110905</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>200 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080918</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567410-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE042635</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567411-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR053542</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEVELOPMENTAL DELAY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITALIN LA</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>021284</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOMOTOR HYPERACTIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEULEPTIL</medicinalproduct>
        <drugdosagetext>10 MG/ML</drugdosagetext>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567412-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066726</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567413-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR062530</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMINOPYRIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567414-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881827-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>ONCE IN A WHILE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROLAIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567415-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066873</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugbatchnumb>UNK.</drugbatchnumb>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF (320/12.5 MG), IN THE MORNING</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugauthorizationnumb>020818</drugauthorizationnumb>
        <drugdosagetext>1 DF (320/12.5 MG), AT NIGHT WHEN SHE IDENTIFIED THAT WAS FEELING BAD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567416-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA005283</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCIDENTAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORNEAL PIGMENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, BID ( PATIENT TOOK GILENYA IN THE MORNING AS USUAL, HOWEVER SHE TOOK IT AGAIN IN THE EVENIN)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MODAFINIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567417-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AR065936</companynumb>
    <primarysource>
      <reportercountry>ARGENTINA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACUTE RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugdosagetext>150 UG, QD</drugdosagetext>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567418-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882646-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567419-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011BR90705</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPITUITARISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMNESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACROMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567420-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA066661</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567421-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR066763</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIMB INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RASILEZ</medicinalproduct>
        <drugauthorizationnumb>21985</drugauthorizationnumb>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1 DF, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567422-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2011US009266</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPLICATION SITE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOCYTE COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEPHAROSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STARING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS STREPTOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0013A</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>300 MG, TID</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICODERM</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALWIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567423-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AT058255</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>25</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSARTHRIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NYSTAGMUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARKEMED</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567424-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB003339</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATATONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TESTICULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567425-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2011GB04591</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OTITIS EXTERNA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>400 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIPIPRAZOLE</medicinalproduct>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>550 MG/ DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070914</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugdosagetext>60 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK UKN, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EAR INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120417</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567426-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012BR044913</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROSUVASTATIN</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugdosagetext>300 UG, BID</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORMOTEROL FUMARATE</medicinalproduct>
        <drugdosagetext>UNK UKN, 3 INHALATIONS DAILY, FOR 6 YEARS AGO</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567427-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066452</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTOLIC DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567428-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854609-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED OTC GERD MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567429-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E2090-02113-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXATIDINE ACETATE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BRAIN OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110815</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567430-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854736-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567431-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855548-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567432-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881584-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567433-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854591-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567434-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855905-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567435-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854715-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110913</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567436-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854682-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567437-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110912</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854432-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110912</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567438-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854620-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110910</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567439-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856200-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567440-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854739-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYPERTENSION MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567441-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854943-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC ARREST</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567442-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881889-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567443-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854882-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567444-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854886-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567445-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854971-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567446-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856156-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567447-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855014-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567448-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881486-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567449-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854705-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567450-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881270-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567451-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012PT066327</companynumb>
    <primarysource>
      <reportercountry>PORTUGAL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ONBREZ</medicinalproduct>
        <drugauthorizationnumb>22383</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567452-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US011888</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.703</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugbatchnumb>S0012</drugbatchnumb>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567453-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CUMIDEN</medicinalproduct>
        <drugdosagetext>2.5-3 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugauthorizationnumb>017963</drugauthorizationnumb>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567454-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US003813</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTOGENS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRATTERA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBEROUS SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIMPAT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567455-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012FR051743</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>3 G DAILY FOR 3 TO 5 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567456-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHFR2012GB004012</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SQUAMOUS CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANTIPSYCHOTIC DRUG LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
        <drugdosagetext>650 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010107</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567457-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871614-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567458-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856813-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED HYPOTHYROID MEDICATION</medicinalproduct>
        <drugdosagetext>ONCE IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567459-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69337</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061031</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567460-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-65565</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP0140101, IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567461-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2011-52425</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEASONAL ALLERGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECZEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP079P0201/IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567462-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2010-38136</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>EP067P0101, IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567463-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856893-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110920</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BESICARE</medicinalproduct>
        <drugindication>POLLAKIURIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567464-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-64629</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BILE DUCT STONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JAUNDICE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>BP088P0104, IP015P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567465-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2011-50634</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART VALVE REPLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP030P0301, DP033P0101; DP038P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567466-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69314</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE ISSUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>KH041H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>16 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567467-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855524-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567468-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69346</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567469-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20080912</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094366</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARANASAL SINUS HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567470-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69334</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567471-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856920-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567472-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855845-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>VARIABLE DOSES</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567473-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2012-69597</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY EMBOLISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567474-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69168</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA00280</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567475-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2012-69502</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567476-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855504-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567477-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567478-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881535-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567479-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871920-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567480-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882462-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567481-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882010-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN PROSTATE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567482-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871642-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567483-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882011-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567484-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882169-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567485-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855737-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567486-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugdosagetext>9 OTHER PILLS THAT PATIENT DID NOT HAVE NAMES FOR</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567487-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882476-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567488-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882256-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567489-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855608-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567490-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882176-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ECHINACEA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567491-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855906-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567492-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882255-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BAYER WOMEN'S ASPIRIN PLUS CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567493-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882174-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG CR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTURNA/HCTZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567494-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855831-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>45 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567495-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882247-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567496-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882181-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567497-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855731-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>NATURE MADE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugdosagetext>EQUATE COMPLETE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567498-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882293-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567499-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856189-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567500-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882642-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEN'S HEALTH ONE A DAY MULTIVITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME, WITH TITRATION TO 2000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567501-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855575-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>68.554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567502-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856199-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567503-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882652-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111211</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567504-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855667-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110916</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567505-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856195-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FREQUENT BOWEL MOVEMENTS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC NON SPECIFIED VIT-B SUPPLEMENTS</medicinalproduct>
        <drugindication>BLOOD HOMOCYSTEINE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567506-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882640-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PINEAPPLE EXTRACTS</medicinalproduct>
        <drugdosagetext>EVERY 3PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567507-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856161-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN GENERIC PRODUCT</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567508-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68032</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AMMONIA ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD SODIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE RELATED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROBACTER BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAILURE TO THRIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>39010101312015</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>12 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567509-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2008-20703</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69.841</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DYAZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP018P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567510-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68785</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP013P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567511-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69264</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PROCEDURE COMPLICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567512-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69128</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUBCUTANEOUS ABSCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567513-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882643-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CYST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567514-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856210-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENOPAUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LDL/HDL RATIO INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HEADACHE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LDL/HDL RATIO DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567515-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110930</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856407-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567516-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882678-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPENEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugdosagetext>EACH MEAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>ONE IN THE MORNING, TWO AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERYTHROMYCIN</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugdosagetext>INHALER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567517-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856310-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567518-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856770-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>81</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OSTEOPOROSIS MEDICATION</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
        <drugdosagetext>SUPPLEMENT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567519-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN DRUG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC PRISTIQ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTURIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567520-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.118</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110919</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567521-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856644-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567522-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68609</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID OVERLOAD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIGHT VENTRICULAR FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>390101,KH041H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>32.5 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567523-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-CH2012-69145</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK , UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITRENDIPIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567524-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69386</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSPLANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567525-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-68062</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP016P0101, IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567526-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0614242-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567527-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882172-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN INHALER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVELOX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567528-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US066804</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>89</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUFFERIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567529-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011AU106007</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLON CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, MANE (IN THE MORNING)</drugdosagetext>
        <drugindication>ARRHYTHMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567530-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US013498</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ROAD TRAFFIC ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugauthorizationnumb>021985</drugauthorizationnumb>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG, Q6H</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110315</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567531-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012US066291</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC TRANSFORMATION STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNRESPONSIVE TO STIMULI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIROFIBRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALTEPLASE</medicinalproduct>
        <drugdosagetext>90 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID SRT</medicinalproduct>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIROFIBRAN</medicinalproduct>
        <drugadministrationroute>040</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567532-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012AU066682</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110808</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100817</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567533-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856471-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BP MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567534-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011AU116273</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERTUSSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugbatchnumb>105627,208152</drugbatchnumb>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567535-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US001562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.54</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567536-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2012DE003128</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYSIPELAS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>TUBEROUS SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110927</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111128</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EVEROLIMUS</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBEROUS SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110926</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BLINDED NO TREATMENT RECEIVED</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBEROUS SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110926</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugdosagetext>DOUBLE BLINDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TUBEROUS SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110926</drugenddate>
        <drugtreatmentduration>288</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567537-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US06797</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO BONE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URETHRAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHOEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL TEST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE EROSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHONDROCALCINOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PENILE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCROTAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL HYPERTROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTICATION DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PATHOLOGICAL FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR CALCIFICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACTERIAL DISEASE CARRIER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMCYT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>2 DF, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALAMINE LOTION</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>1 DF(10/650), QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOTRIMAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
        <drugdosagetext>10 MG, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEFLEX</medicinalproduct>
        <drugdosagetext>500 MG, QID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG, Q6H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050421</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
        <drugdosagetext>250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QOD</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUPRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugdosagetext>7.5 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALOPERIDOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOOST</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567538-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871753-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567539-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015135</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLADEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugauthorizationnumb>021223</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CASODEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RADIOTHERAPY</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567540-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHO2011AU06659</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110407</drugenddate>
        <drugtreatmentduration>415</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AFINITOR</medicinalproduct>
        <drugauthorizationnumb>022334</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL CELL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110303</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567541-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011AU116284</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMMINUTED FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugdosagetext>150 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20021028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>3 MG, NOCTE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110913</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOLEDRONOC ACID</medicinalproduct>
        <drugauthorizationnumb>021817</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITROL</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MYOCARDIAL ISCHAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567542-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012NZ055533</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>6</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugauthorizationnumb>010187</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567543-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2006US02521</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYDRONEPHROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACCESSORY SPLEEN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UROSEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC INFLAMMATORY RESPONSE SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPUTERISED TOMOGRAM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR MARKER INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EJECTION FRACTION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ESCHERICHIA INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARONYCHIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMOXIFEN CITRATE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20000401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>10 MG, Q12H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001009</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugdosagetext>4 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>METASTASES TO BONE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOTERE</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOXAN</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
        <drugdosagetext>150 UG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANASTROZOLE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINORELBINE</medicinalproduct>
        <drugindication>CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HERCEPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRASTUZUMAB</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugdosagetext>5 MG, Q4H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAXOL</medicinalproduct>
        <drugindication>BREAST CANCER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567544-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881948-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567545-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882303-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>ONCE DAILY EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AROUND SIX IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER TABS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567546-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856917-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110905</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567547-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871972-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567548-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-09P-163-0591483-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OILS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSPRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19990101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERY-TABS</medicinalproduct>
        <drugindication>HIDRADENITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567549-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882237-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567550-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856353-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567551-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0872043-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.51</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567552-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881531-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567553-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111211</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882230-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567554-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871981-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULORIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567555-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-10P-163-0635513-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567556-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882468-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567557-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871759-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567558-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855528-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567559-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882235-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567560-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882243-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111207</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567561-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882170-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENITAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567562-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855559-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567563-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856603-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>140.74</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567564-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2011-56160</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>BP087P0101, IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567565-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855514-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugindication>SKIN DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567566-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68656</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567567-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855663-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567568-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AORTIC OCCLUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567569-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2012-68718</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120602</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567570-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-67009</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONCUSSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TICLID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP016P0101, IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051028</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567571-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>84</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY LOSS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567572-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856187-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110904</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567573-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-67349</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP016P0101/IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567574-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-68970</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYSTERECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567575-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855928-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567576-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1093773</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ERIVEDGE</medicinalproduct>
        <drugauthorizationnumb>203388</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567577-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-67717</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA000HD</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>2.5 MCG, UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567578-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69421</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>IP017P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567579-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69374</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>KH041H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>22 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567580-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-67837</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugbatchnumb>MA009PE,MA00ABR</drugbatchnumb>
        <drugauthorizationnumb>021779</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CHANNEL BLOCKERS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567581-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855925-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110916</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567582-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2012-67168</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567583-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856190-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567584-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110918</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856435-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567585-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856219-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567586-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856415-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567587-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856766-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>SUPPLEMENT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PUMPKIN SEED SUPPLEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567588-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-FRI-1000037552</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>60MG DAILY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567589-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-1089285</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101104</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>10-20 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120522</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567590-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ASTELLAS-2012US004704</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FRAXIPARINE                        /01437701/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VANCOMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOREPINEPHRINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL W/POTASSIUM CHLORIDE/SODIUM BICARBON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVIR HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBISOME</medicinalproduct>
        <drugauthorizationnumb>050740</drugauthorizationnumb>
        <drugdosagetext>200 MG, UNKNOWN/D</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BRONCHOPULMONARY ASPERGILLOSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUFENTANIL CITRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567591-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1069135</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567592-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110919</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855758-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugindication>BLADDER SPASM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567593-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-69359</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567594-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69345</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENOUS OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STENT PLACEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL VENOUS CATHETERISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567595-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-60715</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUTURE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATHETER SITE SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPOPROSTENOL SODIUM</medicinalproduct>
        <drugbatchnumb>KH039H0101</drugbatchnumb>
        <drugauthorizationnumb>022260</drugauthorizationnumb>
        <drugdosagetext>18 NG/KG, PER MIN</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567596-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IL-ACTELION-A-CH2012-69304</companynumb>
    <primarysource>
      <reportercountry>ISRAEL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>14</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMYLASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN NOS</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK , UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567597-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2012-69524</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>5 UNK, Q4HRS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567598-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110916</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855521-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567599-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>67</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOTHORAX</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567600-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-ACTELION-A-CH2012-68170</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>44</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>62.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugbatchnumb>EP078P0102</drugbatchnumb>
        <drugauthorizationnumb>21290</drugauthorizationnumb>
        <drugdosagetext>125 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567601-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-60491</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TRANSFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110506</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567602-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-US2012-69379</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugbatchnumb>DP031P0101</drugbatchnumb>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567603-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2012-69556</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>72</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>2.5 ?G, Q4HRS</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567604-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110920</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567605-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ACTELION-A-NJ2012-64714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>8</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL OF LIFE SUPPORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120611</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SILDENAFIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567606-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ACTELION-A-CH2012-69410</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>7</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIEMANN-PICK DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZAVESCA</medicinalproduct>
        <drugauthorizationnumb>021348</drugauthorizationnumb>
        <drugdosagetext>200 MG, OD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NIEMANN-PICK DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080129</drugenddate>
        <drugtreatmentduration>299</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567607-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-1040867</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>80</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE FUMARATE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugbatchnumb>1100549</drugbatchnumb>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>REDUCED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDOCAINE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugbatchnumb>1100549</drugbatchnumb>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO ONSET OF SAE: 09/FEB/2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>INTERMITTEND/ MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>INTERMITTEND</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567608-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA009308</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
        <drugtreatmentduration>2958</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567609-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1207USA009306</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050101</drugenddate>
        <drugtreatmentduration>1460</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>1825</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567610-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1094696</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567611-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201204001951</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLONIC OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A877619D</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567612-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008786</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567613-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207008414</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A888230C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567614-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120729</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ELI_LILLY_AND_COMPANY-CA201207009015</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>103</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VIRAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYTHMOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES                                /UNK/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL                                 /SCH/</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugdosagetext>UNK, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A897247J</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
        <drugtreatmentduration>115</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567615-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201203000036</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120225</drugenddate>
        <drugtreatmentduration>142</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567616-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201203007335</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROLYTE DEPLETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLECYSTECTOMY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 U, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567617-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201206008542</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120422</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>660 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>152</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, OTHER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>909</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>24 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMAC                             /01312301/</medicinalproduct>
        <drugdosagetext>75 UG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567618-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201105006595</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110510</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110511</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567619-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201105001677</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugbatchnumb>A736415C</drugbatchnumb>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROLIA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FORTEO</medicinalproduct>
        <drugauthorizationnumb>021318</drugauthorizationnumb>
        <drugdosagetext>20 UG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567620-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-349813USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>45.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugbatchnumb>33803067A</drugbatchnumb>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567621-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1061260</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOWER GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19860915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19861201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19820101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567622-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1092922</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070213</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567623-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-ROCHE-1091157</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIOVASCULAR INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugauthorizationnumb>020896</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100610</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567624-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-AMGEN-DEUCT2012046877</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPIRUBICIN</medicinalproduct>
        <drugdosagetext>50 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugdosagetext>60 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAPECITABINE</medicinalproduct>
        <drugdosagetext>625 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANITUMUMAB</medicinalproduct>
        <drugdosagetext>9 MG/KG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTRIC CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567625-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1057467</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>72.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORSIG</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugbatchnumb>1100994,1101915</drugbatchnumb>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugdosagetext>LAST DOSE PRIOR TO SAE ON 05 APRIL 2012.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120427</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567626-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1035275</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLANGITIS SCLEROSING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567627-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1057882</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN LOWER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567628-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1062662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMPAIRED GASTRIC EMPTYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19980915</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000914</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010127</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRETINOIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567629-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE53894</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>23635</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENTRICULAR FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOSPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMIFENTANYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELOCURINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIPRIVAN</medicinalproduct>
        <drugauthorizationnumb>19627</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ENDOSCOPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567630-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52714</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567631-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095769</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>COLON CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567632-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1091664</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLETED SUICIDE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ISOTRETINOIN</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugindication>ACNE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567633-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-UCBSA-057270</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STALEVO 100</medicinalproduct>
        <drugdosagetext>100/25/200 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>021829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101126</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGOCALCIFEROL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM D3</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>021829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110628</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PK MERZ</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>021829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>021829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110920</drugenddate>
        <drugtreatmentduration>84</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COSOPT</medicinalproduct>
        <drugdosagetext>20/5 MG, DROPS</drugdosagetext>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>021829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCOMP</medicinalproduct>
        <drugdosagetext>100/25 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111220</drugenddate>
        <drugtreatmentduration>421</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCOMP RETARD</medicinalproduct>
        <drugdosagetext>100/25 MG</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101026</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PK MERZ</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEUPRO</medicinalproduct>
        <drugauthorizationnumb>021829</drugauthorizationnumb>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110315</drugenddate>
        <drugtreatmentduration>109</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRON</medicinalproduct>
        <drugdosagetext>70 OTHER MICROGRAMS</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIMAGON D3</medicinalproduct>
        <drugdosagetext>1250/10 OTHER MICROGRAMS</drugdosagetext>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOCOMP RETARD</medicinalproduct>
        <drugdosagetext>100/25 MG</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101025</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MADOPAR LT</medicinalproduct>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101113</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567634-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA006562</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL FAECES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANALGESIC (UNSPECIFIED)</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL OBSERVATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567635-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1102USA02523</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST-TRAUMATIC STRESS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERPARATHYROIDISM SECONDARY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE PROLAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OBSTRUCTIVE UROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETINOPATHY HYPERTENSIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEPTIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNOVIAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYELID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SURGICAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPINAL OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CERVICAL DYSPLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPENDIX DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICHOTILLOMANIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHOIDS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APICAL GRANULOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB ASYMMETRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY ARTERIAL HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEAFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA OF CHRONIC DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AMINO ACID LEVEL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70MG/2800</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031016</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060622</drugenddate>
        <drugtreatmentduration>981</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060104</drugenddate>
        <drugtreatmentduration>1084</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567636-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ROCHE-1095613</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDEP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA (AUSTRALIA)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODALGIN FORTE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOVIT (CALCIUM/VIT D)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567637-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-BAYER-2012-053032</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE INDURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE EXTRAVASATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIPLEGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE SCAB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugbatchnumb>13261A</drugbatchnumb>
        <drugdosagetext>1 ML, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETAJECT COMFORT</medicinalproduct>
        <drugindication>DEVICE THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567638-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096597</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>30</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567639-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-50794-11041475</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>35</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B12</medicinalproduct>
        <drugdosagetext>1500 MICROGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>75 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110330</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110330</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugdosagetext>75 MICROGRAM/SQ. METER</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110329</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARMODAFINIL</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110330</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXJADE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIGMART</medicinalproduct>
        <drugdosagetext>15 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>2.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE DINITRATE</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORMS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOTEC</medicinalproduct>
        <drugdosagetext>600 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567640-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-577338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.9</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTROPHIC ANAL PAPILLA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP DRY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIUM DIFFICILE COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ILEUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALNUTRITION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTOCOLITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAZORAC</medicinalproduct>
        <drugindication>ACNE CYSTIC</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030410</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030908</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030409</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567641-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51312</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567642-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE52722</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>38</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567643-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1096862</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED UPPER AIRWAY SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRODUCTIVE COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT CONGESTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567644-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE286160</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM ST SEGMENT ELEVATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL ISCHAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ELECTROCARDIOGRAM T WAVE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TENECTEPLASE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567645-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-791899</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPOSARCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567646-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-624493</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISLOCATION OF VERTEBRA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENOUS THROMBOSIS LIMB</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENINGIOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT DISLOCATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>FORM: ORAL FORMULATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081021</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081021</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100907</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100907</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METALCAPTASE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090814</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090814</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugdosagetext>INFUSION RATE DECREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090612</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090612</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091006</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091006</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101005</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101005</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ITRACONAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090707</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELECOXIB</medicinalproduct>
        <drugdosagetext>DRUG: CELECOX.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100323</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100323</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
        <drugdosagetext>FORM: ORAL FORMULATION (NOT OTHERWISE SPECIFIED).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugdosagetext>DRUG: BONALON 35MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090113</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100420</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100420</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>INFUSION RATE DECREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567647-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17356BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567648-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PH-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-CS-01124RP</companynumb>
    <primarysource>
      <reportercountry>PHILIPPINES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRAJENTA</medicinalproduct>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567649-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010250</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
        <drugtreatmentduration>4018</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567650-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN004992</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NONSTEROIDAL ANTI-INFLAMMATORY DRUG (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIPHERAL OPIOID RECEPTOR ANTAGONIST (UNSPECIFIED)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugauthorizationnumb>012675</drugauthorizationnumb>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567651-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-GNE323731</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACRIMATION INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>225 MG, Q2W</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567652-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-349874USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567653-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2012SE53111</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>32</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COMPLICATION OF PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MATERNAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugauthorizationnumb>019810</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567654-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1107USA01808</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FRACTURE NONUNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FRACTURE DELAYED UNION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL RUPTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BASAL CELL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP COLORECTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTOCELE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ERUPTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDIASTINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMPYEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERMITTENT CLAUDICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL ARTERIAL OCCLUSIVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAT NECROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080827</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
        <drugtreatmentduration>2989</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19710101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567655-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077933</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567656-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CL-BAYER-2012-043206</companynumb>
    <primarysource>
      <reportercountry>CHILE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMPERIDONE</medicinalproduct>
        <drugdosagetext>30 MG/SOS</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101203</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIMETICONE</medicinalproduct>
        <drugdosagetext>200 MG</drugdosagetext>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOXACILLIN SODIUM</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugindication>SKIN INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110615</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXAVAR</medicinalproduct>
        <drugbatchnumb>06145</drugbatchnumb>
        <drugauthorizationnumb>021923</drugauthorizationnumb>
        <drugdosagetext>400 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAFORNIL</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>2 MG</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111020</drugenddate>
        <drugtreatmentduration>276</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110903</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101104</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>DAILY DOSE 50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 3 G</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugbatchnumb>218428</drugbatchnumb>
        <drugdosagetext>150 MG/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATIC NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120510</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK OF MAGNESIA TAB</medicinalproduct>
        <drugdosagetext>2 CAPS, UNK</drugdosagetext>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110902</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>20 MG PER PROCEDURE</drugdosagetext>
        <drugindication>DIAGNOSTIC PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
        <drugtreatmentduration>516</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DINAFLEX</medicinalproduct>
        <drugdosagetext>1 PILL, UNK</drugdosagetext>
        <drugindication>ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110928</drugenddate>
        <drugtreatmentduration>65</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS CARBONATE</medicinalproduct>
        <drugdosagetext>1 COMP</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORDIAZEPOXIDE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>ABDOMINAL DISTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101121</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
        <drugdosagetext>DAILY DOSE 7.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLO [DICLOFENAC SODIUM]</medicinalproduct>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>OROPHARYNGEAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100924</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>57</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIRAY 160</medicinalproduct>
        <drugdosagetext>100 ML PER PROCEDURE</drugdosagetext>
        <drugindication>IMAGING PROCEDURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101112</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120410</drugenddate>
        <drugtreatmentduration>516</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>6 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110908</drugenddate>
        <drugtreatmentduration>225</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>1 COMP.QD</drugdosagetext>
        <drugindication>PROSTATISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110324</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110402</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLAFORNIL</medicinalproduct>
        <drugdosagetext>750 MG</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110131</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1 GR</drugdosagetext>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101130</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY DOSE 40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NEPHROTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567657-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2012SE52725</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>1 DF TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>SLEEP APNOEA SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZITHROMYCIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIOTROPIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugdosagetext>1 DF TWO TIMES A DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567658-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-1096956</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCAL REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUNISOLIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE/SALMETEROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORPHENIRAMINE MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugbatchnumb>S0044/S2011</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567659-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-028100</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE DISLOCATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120303</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567660-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16665BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZANTAC 150</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021698</drugauthorizationnumb>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567661-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-CELGENEUS-087-21880-12052783</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EOSINOPHILIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SICK SINUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugdosagetext>12 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugdosagetext>12 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>7.5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE ACETATE</medicinalproduct>
        <drugdosagetext>40 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120515</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>1 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGMITT</medicinalproduct>
        <drugdosagetext>990 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE ACETATE</medicinalproduct>
        <drugdosagetext>5.7143 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>60 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMODIN OD</medicinalproduct>
        <drugdosagetext>5 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>120 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>100 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATHEROSCLEROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RABEPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>180 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567662-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-494040</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABLE BOWEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRON DEFICIENCY ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZAMYCIN</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACNE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010428</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010429</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20010521</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20020701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567663-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-751887</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.3</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAL FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS INTESTINAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ULCERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCUTANEOUS FISTULA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATORY BOWEL DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACCUTANE</medicinalproduct>
        <drugauthorizationnumb>018662</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ACNE CYSTIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>19991001</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567664-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ASTRAZENECA-2012SE52811</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DACRYOSTENOSIS ACQUIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugdosagetext>40 MG, BID AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567665-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP014474</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
        <drugtreatmentduration>26</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120311</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM FERROUS CITRATE</medicinalproduct>
        <drugdosagetext>100 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL</medicinalproduct>
        <drugdosagetext>UPDATE (10 MAY 2012)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120306</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INVESTIGATIONAL DRUG (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>2250 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugdosagetext>2250 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120120</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2B</medicinalproduct>
        <drugdosagetext>1.5 ?G/KG, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120219</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>10 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEROTYM</medicinalproduct>
        <drugdosagetext>100 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>IRON DEFICIENCY ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugdosagetext>2 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>400 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120411</drugenddate>
        <drugtreatmentduration>31</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN REDITABS</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PITAVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugdosagetext>1500 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPADEL S</medicinalproduct>
        <drugdosagetext>1800 MG, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567666-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53387</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567667-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ASTRAZENECA-2012SE36044</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STENT PLACEMENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ACUTE MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APROVAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567668-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-JNJFOC-20120801728</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567669-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120801638</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>022406</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIP SURGERY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567670-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120800190</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>42</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NICOTINE DEPENDENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTINE</medicinalproduct>
        <drugbatchnumb>B000105190</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567671-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120607954</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.3</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>LESS THAN HALF DOSAGE RECEIVED.</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120725</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020909</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567672-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120715343</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALLOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFUSION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>15TH INFUSION</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567673-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120712997</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAPHYLACTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MASTOCYTOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567674-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120401618</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090207</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101208</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567675-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-JNJFOC-20120703457</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>USTEKINIMAB</medicinalproduct>
        <drugdosagetext>DOSAGE WAS TEMPORARILY STOPPED</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100929</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120713</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567676-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-JNJFOC-20120801746</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POST PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LERCANIDIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugauthorizationnumb>202439</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120628</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567677-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206009181</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567678-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007244</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SELF INJURIOUS BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugindication>AGITATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567679-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201208000507</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONGENITAL DIAPHRAGMATIC HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110820</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120320</drugenddate>
        <drugtreatmentduration>214</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567680-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207006432</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLINERGIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONEPEZIL HCL</medicinalproduct>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugindication>SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE</drugindication>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567681-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206007389</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC BYPASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, EACH EVENING</drugdosagetext>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>15 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIOTHYRONINE SODIUM</medicinalproduct>
        <drugdosagetext>25 UG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugdosagetext>200 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HALDOL</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>DYSPHORIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESPERAL</medicinalproduct>
        <drugdosagetext>3 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugdosagetext>45 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugdosagetext>2 MG, PRN</drugdosagetext>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugdosagetext>15 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugdosagetext>4 MG, EACH EVENING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>30 MG, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567682-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201206003523</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>16</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD THROMBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOTIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugdosagetext>2.5 MG, PRN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>15 MG, QD</drugdosagetext>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugdosagetext>5 MG, PRN</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120521</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZUCLOPENTHIXOL</medicinalproduct>
        <drugdosagetext>50 MG, SINGLE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PSYCHOTIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567683-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-ELI_LILLY_AND_COMPANY-IE201207007808</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEROTONIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISSEMINATED INTRAVASCULAR COAGULATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567684-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007331</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHLORIDE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A945043A</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A937934A</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>19</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567685-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007520</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONGENITAL DIAPHRAGMATIC HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>FIBROMYALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS                  /01549301/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENATAL VITAMINS                  /01549301/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120319</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567686-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007476</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC CIRRHOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50 MG, QID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>137 DF, QD</drugdosagetext>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1 DF, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B 12 LICHTENSTEIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugdosagetext>75 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>250 MG, UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>5 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567687-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-ELI_LILLY_AND_COMPANY-PE201207007248</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugbatchnumb>A864809F</drugbatchnumb>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567688-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007202</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOVERSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC PACEMAKER INSERTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CRYING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEG AMPUTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APPETITE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOMYELITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FINGER AMPUTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLEMASTINE FURARATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILANTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEXILETINE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLCYSTEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugbatchnumb>A962894A</drugbatchnumb>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>40 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugauthorizationnumb>018936</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567689-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007296</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROSTOMY TUBE INSERTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugbatchnumb>A955994C</drugbatchnumb>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>120MG, DAILY</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugdosagetext>20MG TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>ONCE DAILY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARBIDOPA AND LEVODOPA</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINIROLE</medicinalproduct>
        <drugdosagetext>0.5MG, TID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567690-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201102000555</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ISCHAEMIC STROKE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYDRIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBELLAR HAEMATOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLADDER DILATATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>8 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101202</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101208</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugdosagetext>6 D/F, DAILY (1/D)</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERCIAN</medicinalproduct>
        <drugdosagetext>25 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERSECUTORY DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101202</drugenddate>
        <drugtreatmentduration>147</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXAPINE HCL</medicinalproduct>
        <drugdosagetext>25 MG, 4/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERSECUTORY DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101208</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL CONSTA</medicinalproduct>
        <drugdosagetext>UNK, OTHER ONE INTAKE</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PERSECUTORY DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101203</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101203</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERSECUTORY DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>138</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugdosagetext>1 D/F, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101206</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101208</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugdosagetext>2 MG, 3/D</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PERSECUTORY DELUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101201</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEPTICUR</medicinalproduct>
        <drugdosagetext>10 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>EXTRAPYRAMIDAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101208</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMOVANE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567691-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206009721</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.633</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, QD</drugdosagetext>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120619</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567692-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007654</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORNEAL PERFORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLINDNESS UNILATERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES OPHTHALMIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567693-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ELI_LILLY_AND_COMPANY-JP201207005244</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>1</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>NEONATAL RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION NEONATAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567694-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201206004602</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>77</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567695-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>90 MG, TAKES 60 MG AND 30 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567696-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201112002549</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEGACOLON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTI-ORGAN FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYSTEMIC CANDIDA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>20MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>021253</drugauthorizationnumb>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>25MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111128</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567697-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007322</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PAIN</drugindication>
        <drugtreatmentduration>1095</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567698-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201207006593</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATITIS CHOLESTATIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THERALENE</medicinalproduct>
        <drugdosagetext>20 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>7.5 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120302</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567699-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ELI_LILLY_AND_COMPANY-DE201206006359</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSIVE CRISIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugauthorizationnumb>022173</drugauthorizationnumb>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>7.5MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567700-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ELI_LILLY_AND_COMPANY-GB201207007640</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>13</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYANOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATOMOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021411</drugauthorizationnumb>
        <drugdosagetext>40 MG, QD</drugdosagetext>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
        <drugtreatmentduration>343</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>27 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091110</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110327</drugenddate>
        <drugtreatmentduration>503</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>27 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CONCERTA</medicinalproduct>
        <drugdosagetext>36 MG, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567701-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ELI_LILLY_AND_COMPANY-FR201003004832</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>20 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100107</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100112</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugauthorizationnumb>020592</drugauthorizationnumb>
        <drugdosagetext>5 MG, DAILY (1/D)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567702-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100219</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0845465A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>35</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENTAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERFORMANCE STATUS DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INDIFFERENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLAT AFFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECONOMIC PROBLEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEARING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECT LABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GENERALISED ANXIETY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NO CONCURRENT MEDICATION</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567703-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-GLAXOSMITHKLINE-A0950563A</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MACULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELTROMBOPAG</medicinalproduct>
        <drugauthorizationnumb>022291</drugauthorizationnumb>
        <drugdosagetext>25MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567704-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0976997A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>1.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AUTISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCOLIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLEFT LIP AND PALATE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REGLAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567705-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0977032A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS CORONARY ARTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOMYOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSIENT ISCHAEMIC ATTACK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDAMET</medicinalproduct>
        <drugauthorizationnumb>021410</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugauthorizationnumb>021071</drugauthorizationnumb>
        <drugdosagetext>8MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567706-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0977191A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CYTOGENETIC ABNORMALITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TALIPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567707-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0981550A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugauthorizationnumb>021077</drugauthorizationnumb>
        <drugdosagetext>1PUFF TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567708-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988128A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MICROCEPHALY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugdosagetext>20MG PER DAY</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567709-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesscongenitalanomali>1</seriousnesscongenitalanomali>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GLAXOSMITHKLINE-A0988144A</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKULL MALFORMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOETAL EXPOSURE DURING PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugauthorizationnumb>020031</drugauthorizationnumb>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567710-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-GLAXOSMITHKLINE-B0766014A</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRAIN NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYKERB</medicinalproduct>
        <drugauthorizationnumb>022059</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BREAST CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111014</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111014</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567711-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GR-GLAXOSMITHKLINE-B0815557A</companynumb>
    <primarysource>
      <reportercountry>GREECE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACENOCOUMAROL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugauthorizationnumb>019151</drugauthorizationnumb>
        <drugdosagetext>75MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXELON</medicinalproduct>
        <drugdosagetext>6ML TWICE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLECALCIFEROL + CALCIUM CARBONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567712-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE50528</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>105.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>APHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20040101</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567713-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE53434</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugauthorizationnumb>021929</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567714-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE25965</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>449</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TONSILLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugauthorizationnumb>022047</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BIPOLAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120322</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567715-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1013479</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALPROIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTANE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>075417</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>075417</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOPHRENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567716-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012609</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.0MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>22</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
        <drugtreatmentduration>29</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567717-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010297</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>2379</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100601</drugenddate>
        <drugtreatmentduration>2379</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567718-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012624</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>200 AND 400 IN EVENING IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80MCG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567719-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010328</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110401</drugenddate>
        <drugtreatmentduration>1220</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567720-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MERCK-1207USA011033</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>20 MG, HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567721-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2011SP014621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENDOMETRIOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SPEECH DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYCYSTIC OVARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENITAL INFECTION FUNGAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEMIPARESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATEMESIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD POTASSIUM ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>1500 MG, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>021187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090426</drugenddate>
        <drugtreatmentduration>274</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAMOX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN/HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXERT</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugindication>PULMONARY EMBOLISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567722-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078467</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567723-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078582</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.027</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA LIKE ILLNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>250 ?G, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567724-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350571USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PELVIC PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD SWINGS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VAGINAL DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567725-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1012USA02525</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPOROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PEDAL PULSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VEIN PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIVERTICULUM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE FRACTURES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID BRUIT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLYP COLORECTAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC MURMUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MITRAL VALVE DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAIR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MAJOR DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DENTAL CARIES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL SEPTUM DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL VASCULAR DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY HEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VARICOSE VEIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTERIOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HORMONE LEVEL ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST CANCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081207</drugenddate>
        <drugtreatmentduration>3650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090803</drugenddate>
        <drugtreatmentduration>456</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567726-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010976</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>120 MG, TID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>91</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567727-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012646</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>49</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5G/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SELBEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120626</drugenddate>
        <drugtreatmentduration>70</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567728-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100413</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-009507513-2010SP021297</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>800 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>25 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 ?G, QW</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>HEPATITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LACIREX</medicinalproduct>
        <drugdosagetext>2 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567729-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000621</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugauthorizationnumb>022044</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567730-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12053041</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101228</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
        <drugtreatmentduration>123</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567731-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351064USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.026</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567732-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17017BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567733-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17019BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>94</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567734-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16251BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021527</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19930101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>240 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NERVOUS SYSTEM DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567735-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16253BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567736-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16244BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120707</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567737-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010304</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
        <drugtreatmentduration>4117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
        <drugtreatmentduration>4117</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567738-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-2012SP022962</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUBARACHNOID HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>600 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
        <drugtreatmentduration>111</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXOPROFEN</medicinalproduct>
        <drugdosagetext>TAKE AS NEED FOR PAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugdosagetext>60 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 MICROGRAM, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugdosagetext>TAKE AS NEED FOR PAIN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>80 ?G, QW</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120419</drugenddate>
        <drugtreatmentduration>105</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567739-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16677775</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTEROCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugdosagetext>ON DAYS 1,8,15,22</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>ON DAYS 1,8,15,22</drugdosagetext>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugauthorizationnumb>086358</drugauthorizationnumb>
        <drugdosagetext>DAY15</drugdosagetext>
        <drugadministrationroute>037</drugadministrationroute>
        <drugindication>ACUTE LYMPHOCYTIC LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELSPAR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567740-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16829814</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPRYCEL</medicinalproduct>
        <drugauthorizationnumb>021986</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567741-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120801249</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>3</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientweight>3.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugdosagetext>30MG CODEINE, 300 MG ACETAMINOPHEN</drugdosagetext>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>EXPOSURE DURING BREAST FEEDING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567742-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-JNJFOC-20120801250</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>2</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG SCREEN POSITIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST FEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
        <drugauthorizationnumb>085055</drugauthorizationnumb>
        <drugadministrationroute>063</drugadministrationroute>
        <drugindication>EXPOSURE DURING BREAST FEEDING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567743-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16706087</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TEMPORAL ARTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 20JUN2012 RESTARTED 28JUN12: 720 MG,COURSE:1,STOP DT:09JUL2012</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + MAGNESIUM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111007</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IPILIMUMAB</medicinalproduct>
        <drugdosagetext>INTERRUPTED ON 21JUN2012 RECEIVED DOSE ON 12JUL2012</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111010</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567744-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010995</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567745-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011030</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567746-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010961</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567747-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AR-BRISTOL-MYERS SQUIBB COMPANY-16798993</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PANCREATITIS ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ENTECAVIR</medicinalproduct>
        <drugauthorizationnumb>021797</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS B</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080131</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567748-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE53158</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>898</patientonsetage>
      <patientonsetageunit>802</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDON RUPTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSLIPIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IKOREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EUPANTHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOPTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THEOPHYLLINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567749-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-073732</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>28</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE DIFFICULT TO USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCEDURAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugbatchnumb>TU00ER1</drugbatchnumb>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120719</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567750-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351617USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugauthorizationnumb>021457</drugauthorizationnumb>
        <drugdosagetext>720 MICROGRAM;</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567751-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MYLANLABS-2012S1015735</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>6C0145</drugbatchnumb>
        <drugauthorizationnumb>76258</drugauthorizationnumb>
        <drugdosagetext>CHANGED Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FENTANYL</medicinalproduct>
        <drugbatchnumb>6C0145</drugbatchnumb>
        <drugauthorizationnumb>076258</drugauthorizationnumb>
        <drugdosagetext>CHANGED Q72H</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567752-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OPTIC NEURITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003357</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567753-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7124111</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS RELAPSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PELVIC FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATION</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567754-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150967</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER EXTREMITY MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE HAEMATOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002604</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567755-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7150771</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567756-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7151301</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567757-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-CELGENEUS-062-50794-12050960</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELODYSPLASTIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERAL PHYSICAL HEALTH DETERIORATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOCYTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugauthorizationnumb>050794</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120126</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120307</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIDAZA</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111229</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567758-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2012SE46022</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FUNCTION ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HANGESHASHINTO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>21153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KOSOSAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHILLS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567759-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-TEVA-350057ISR</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION RELATED REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METASTASES TO CENTRAL NERVOUS SYSTEM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTICTAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>77269</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALIMTA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER EXTENSIVE STAGE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567760-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51678</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567761-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011124</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUCOSAL EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>61</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567762-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012653</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ASCITES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567763-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012651</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION (BEPOTASTINE BESYLATE)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>60MG/DAY AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>0.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugauthorizationnumb>020903</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.2MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.0MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADERM</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>[THERAPY UNSPECIFIED]</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567764-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51671</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>55</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugauthorizationnumb>021366</drugauthorizationnumb>
        <drugdosagetext>ONCE A DAY FOR ONLY ONE WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567765-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-077925</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEVICE EXPULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRENA</medicinalproduct>
        <drugauthorizationnumb>021225</drugauthorizationnumb>
        <drugdosagetext>20 MCG/24HR, CONT</drugdosagetext>
        <drugadministrationroute>015</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567766-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-FABR-1002662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FABRAZYME</medicinalproduct>
        <drugbatchnumb>UNK</drugbatchnumb>
        <drugdosagetext>45 MG, Q2W</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>FABRY'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567767-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GENZYME-POMP-1002282</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA MULTIFORME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA FUNGAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LUMIZYME</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>10 MG/KG, QW</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GLYCOGEN STORAGE DISEASE TYPE II</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120618</drugenddate>
        <drugtreatmentduration>139</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPHOTERICIN B</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567768-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ASTRAZENECA-2012SE53801</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH ABSCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHONCHI</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY DISTRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTHACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERVENTILATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABSCESS NECK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIOTOXICITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED LEVEL OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EMOTIONAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOSSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RETCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THINKING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENTERITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG EFFECT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TARDIVE DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EATING DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UMBILICAL HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE</medicinalproduct>
        <drugauthorizationnumb>020639</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080701</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567769-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-350403USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST ENLARGEMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120705</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567770-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20110203662</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>46.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SYSTEMIC LUPUS ERYTHEMATOSUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9JD83012P1;09K034P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9JD83012P1;09K034P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9JD83012P1;09K034P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MESALAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9JD83012P1;09K034P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9JD83012P1;09K034P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>INFLAMMATORY BOWEL DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugbatchnumb>9JD83012P1;09K034P1 +MORE</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100809</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100809</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567771-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20110908017</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INFLIXIMAB, RECOMBINANT</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567773-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ELI_LILLY_AND_COMPANY-BR201205006018</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugauthorizationnumb>020563</drugauthorizationnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567774-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ELI_LILLY_AND_COMPANY-CO201207008511</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>40</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOCALISED INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERGLYCAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>4 IU, QD</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567775-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007543</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE FLUCTUATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETIC NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSULIN RESISTANT DIABETES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugbatchnumb>A919953D</drugbatchnumb>
        <drugauthorizationnumb>018780</drugauthorizationnumb>
        <drugdosagetext>UNK, PRN</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567776-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ASTRAZENECA-2012SE53159</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>27</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567777-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-US-EMD SERONO, INC.-7151430</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CENTRAL NERVOUS SYSTEM LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>019764</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>GROWTH HORMONE DEFICIENCY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120715</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567778-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-US-EMD SERONO, INC.-7151046</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SAIZEN</medicinalproduct>
        <drugauthorizationnumb>019764</drugauthorizationnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>BRAIN NEOPLASM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567779-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-347797USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENSTRUATION DELAYED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENSTRUATION IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567780-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-TEVA-351383USA</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ECTHYMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSEUDOMONAS INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPOGEN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>63097</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENOXAPARIN SODIUM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA STAGE IV</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>B-CELL LYMPHOMA STAGE IV</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567781-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-JNJFOC-20120109458</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CROHN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYELOID LEUKAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLIMARA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>DISCONTINUED JUNE OR AUGUST 2008</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIBIOTICS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IMURAN</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugdosagetext>START DATE APPROXIMATELY JUNE OR AUGUST</drugdosagetext>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567782-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA011238</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHABDOMYOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRANSAMINASES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>360 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugauthorizationnumb>019766</drugauthorizationnumb>
        <drugdosagetext>80 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>240 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MARCUMAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567783-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120608</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000823</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC PRODUCT INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugauthorizationnumb>022015</drugauthorizationnumb>
        <drugdosagetext>UNK, ONCE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567784-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000037383</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST-TRAUMATIC STRESS DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567785-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-FRI-1000022729</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LYMPHADENOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUS SYSTEM DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110805</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIIBRYD</medicinalproduct>
        <drugauthorizationnumb>022567</drugauthorizationnumb>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110804</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110804</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567786-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16358BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>265515A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugdosagetext>10 PUF</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567787-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17076BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567788-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16323BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA EXERTIONAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>150 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567789-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-AMGEN-JPNCT2012048474</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUSO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPENON</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DARBEPOETIN ALFA - KHK</medicinalproduct>
        <drugdosagetext>6 MUG, Q4WK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRECIPITATED CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETIC NEPHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567790-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16604BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>265507A,165600A</drugbatchnumb>
        <drugauthorizationnumb>021747</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>EMPHYSEMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567791-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16464BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>165618A</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567792-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16672BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020291</drugauthorizationnumb>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>BRONCHITIS CHRONIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567793-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17016BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT ROUTE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021395</drugauthorizationnumb>
        <drugdosagetext>18 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120727</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567794-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-ASTELLAS-2012US006675</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION BACTERIAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TARCEVA</medicinalproduct>
        <drugauthorizationnumb>021743</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111015</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120315</drugenddate>
        <drugtreatmentduration>153</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567795-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16793846</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>109</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE CONGESTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugauthorizationnumb>009218</drugauthorizationnumb>
        <drugdosagetext>INTER ON 29APR12(1 YEAR).</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>27OCT11-29APR12(186 DAYS) 08MAY12-ONG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111027</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIGRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANAEMIA PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNKN-29APR12 08MAY12-ONG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIVE</medicinalproduct>
        <drugindication>DRY EYE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>LANTUS SOLOSTAR</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567796-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1092332</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PREGNANCY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567797-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ROCHE-1084007</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SEPTIC SHOCK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAVENTRICULAR HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THALAMUS HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugdosagetext>ONLY AT FRIDAY AND SATURDAY AT MONDAY AND WEDNESDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRCERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEPHROGENIC ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>DISCONTINUANCE AT MORNING OF DIALYSIS DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RENAGEL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERPHOSPHATAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENLES</medicinalproduct>
        <drugdosagetext>SOIL AT TUESDAY AND THURSDAY</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PUNCTURE SITE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PURSENNID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVORAPID</medicinalproduct>
        <drugdosagetext>IT IS 18 UNITS ON THE MORNING OF THE DIALYSIS DAY.</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567798-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>RO-ROCHE-1093403</companynumb>
    <primarysource>
      <reportercountry>ROMANIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERECTILE DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567799-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN001479</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>1.5MCG/KG/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URSO 250</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TELAPREVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ADVERSE EVENT</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEO-MINOPHAGEN C</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELESTAMINE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567800-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-FRI-1000037552</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACTIVITIES OF DAILY LIVING IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WITHDRAWAL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVERDOSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SSRI</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>60MG DAILY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>80 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567801-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1085962</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567802-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ROCHE-1092847</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080221</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567803-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-ROCHE-796033</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAROTITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AORTIC STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION, VISUAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCLOX</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567804-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-ROCHE-1095661</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CHLORAMINOPHENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120630</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567805-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ROCHE-1091854</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COGNITIVE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>QUALITY OF LIFE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSON'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CEREBRAL THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMOCYSTIS JIROVECI PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEORAL</medicinalproduct>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567806-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>TR-PFIZER INC-2012185244</companynumb>
    <primarysource>
      <reportercountry>TURKEY</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENDOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>007073</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANKYLOSING SPONDYLITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567807-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012173817</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567808-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012119758</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>54</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>82</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>100 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugbatchnumb>64199</drugbatchnumb>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>88 UG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INSULIN RESISTANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugauthorizationnumb>021301</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567809-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012160853</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>79</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CYSTITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG/M2, CYCLIC (EVERY 21 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIZIDE</medicinalproduct>
        <drugdosagetext>40/12.5 MG, ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CETUXIMAB</medicinalproduct>
        <drugdosagetext>250 MG/M2, CYCLIC (DAY 1 AND 8 EVERY 15 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>180 MG/M2, CYCLIC (EVERY 15 DAYS)</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2900 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567810-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012183674</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIOVENTRICULAR BLOCK SECOND DEGREE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugauthorizationnumb>020699</drugauthorizationnumb>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>30 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567811-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012126174</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567812-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2010080623</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.76</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL MUCOSAL BLISTERING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>200MG 2X/DAY AND 150MG 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN MANAGEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NICOTROL</medicinalproduct>
        <drugauthorizationnumb>020714</drugauthorizationnumb>
        <drugdosagetext>10 MG (2 PUFFS AS NEEDED)</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100608</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100611</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567813-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012182153</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEBIVOLOL</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120613</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugdosagetext>1 DF, 1X/DAY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PERINDOPRIL ERBUMINE</medicinalproduct>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>160 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567814-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012121340</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOACUSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>10 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugauthorizationnumb>019684</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567815-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012146993</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>57</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSED MOOD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>FOLLOW-ON PACK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>1 PILL IN THE MORNING AND 1 IN THE EVENING (STARTER PACK)</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567816-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-PFIZER INC-2012144394</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OLIGURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GYNAECOMASTIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100 UNK, 1X/DAY IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040310</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugbatchnumb>B10558830PO</drugbatchnumb>
        <drugauthorizationnumb>019668</drugauthorizationnumb>
        <drugdosagetext>4 MG, ONE TABLET ONCE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>81</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>UNK, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080610</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEVASC</medicinalproduct>
        <drugdosagetext>ONE TABLET, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090505</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACLOTIN</medicinalproduct>
        <drugdosagetext>ONE TABLET, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19970927</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567817-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2011174097</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>73</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>4 MG, 1X/DAY FROM RANDOMIZATION</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080129</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081222</drugenddate>
        <drugtreatmentduration>329</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY, UNTIL RANDOMIZATION</drugdosagetext>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071227</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080128</drugenddate>
        <drugtreatmentduration>33</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090622</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100617</drugenddate>
        <drugtreatmentduration>361</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAPAMUNE</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080128</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081222</drugenddate>
        <drugtreatmentduration>330</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROGRAF</medicinalproduct>
        <drugdosagetext>2 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081223</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090621</drugenddate>
        <drugtreatmentduration>181</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMIVUDINE</medicinalproduct>
        <drugdosagetext>UNKNOWN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567818-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012177278</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>70</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEBRILE BONE MARROW APLASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugdosagetext>50 MG, CYCLIC</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>375 MG/M2, CYCLIC</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FASTURTEC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>2G/M2</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLARAMINE</medicinalproduct>
        <drugindication>PREMEDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GRANOCYTE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120708</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567819-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012176321</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.095</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTESTINAL OBSTRUCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>175 UG, 2X/WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SUNITINIB MALATE</medicinalproduct>
        <drugauthorizationnumb>021938</drugauthorizationnumb>
        <drugdosagetext>37.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THYROID CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugdosagetext>100 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>150 UG, 5 TIMES A WEEK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVETIRACETAM</medicinalproduct>
        <drugdosagetext>750 MG, LONG ACTING, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567820-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2012176006</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>73</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGITOXIN</medicinalproduct>
        <drugdosagetext>0.2 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120721</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>22088</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120709</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>050484</drugauthorizationnumb>
        <drugdosagetext>117.6 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugdosagetext>5 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>1 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG, 1X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMSIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>022088</drugauthorizationnumb>
        <drugdosagetext>12.5 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugdosagetext>195.9 MG, PER 24 HOURS VIA PERFUSOR; STANDARD INDUCTION THERAPY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>ACUTE LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567821-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012124284</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>77</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIC SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL BACTERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADCAL-D3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugauthorizationnumb>7073</drugauthorizationnumb>
        <drugdosagetext>GRADUALLY INCREASING DOSE TO 1G TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120428</drugenddate>
        <drugtreatmentduration>43</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KENALOG</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISOLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567822-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012154673</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPRAVENTRICULAR TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>166 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTILIUM</medicinalproduct>
        <drugdosagetext>10 MG, 4X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>234 MG, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>99</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENSURE</medicinalproduct>
        <drugdosagetext>1 CAN, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MEDICAL DIET</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMMUNE GLOBULIN (HUMAN)</medicinalproduct>
        <drugdosagetext>45 G, MONTHLY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IMMUNE ENHANCEMENT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>VITAMIN B12 INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
        <drugdosagetext>40 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAX-A-DAY</medicinalproduct>
        <drugdosagetext>17 G, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XELODA</medicinalproduct>
        <drugdosagetext>1450 MG, 2X/DAY FOR 14 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120627</drugenddate>
        <drugtreatmentduration>98</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT</medicinalproduct>
        <drugdosagetext>8 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXERAN</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>1 TO 2 TABLETS AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugdosagetext>200 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120323</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugdosagetext>0.6 MG, UNK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>2 TABLETS, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXERAN</medicinalproduct>
        <drugdosagetext>10 MG, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLACTIC CHEMOTHERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567823-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-PFIZER INC-2012163143</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>400 MG/M2, ON DAY ONE OF EACH 14 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>400 MG/M2, ON DAY ONE OF EACH 14 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ABDOMINAL PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>2400 MG/M2, ON DAYS ONE AND TWO OF EACH 14 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>180 MG/M2, ON DAY ONE OF EACH 14 DAY CYCLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>COLORECTAL CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PASPERTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS OF NAUSEA AND VOMITING</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLAXOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567824-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2011316499</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>37</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISEASE PROGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAMORPH SR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugauthorizationnumb>040023</drugauthorizationnumb>
        <drugdosagetext>2400 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRIVANIB ALANINATE</medicinalproduct>
        <drugdosagetext>600 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HCL</medicinalproduct>
        <drugauthorizationnumb>20571</drugauthorizationnumb>
        <drugdosagetext>180 MG/M2, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>GASTROINTESTINAL CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111109</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>85</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567825-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012183566</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>64</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SURGERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RELPAX</medicinalproduct>
        <drugauthorizationnumb>021016</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567826-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-ASTRAZENECA-2012SE53805</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>60</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MELAENA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINE ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SMALL INTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567827-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012154004</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HODGKIN'S DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugauthorizationnumb>020702</drugauthorizationnumb>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567828-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012182064</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>66</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugdosagetext>20 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROX 50</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugauthorizationnumb>20702</drugauthorizationnumb>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVONORM 1</medicinalproduct>
        <drugdosagetext>1 DF, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RAMIPRIL BIOGARAN</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMINE BIOGARAN</medicinalproduct>
        <drugdosagetext>1 G, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BISOPROLOL BIOGARAN</medicinalproduct>
        <drugdosagetext>5 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120526</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE</medicinalproduct>
        <drugdosagetext>^200^</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567829-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1084211</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMMOBILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MABTHERA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>IDIOPATHIC THROMBOCYTOPENIC PURPURA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPICLONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL W/ CODEINE NO. 3</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567830-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BE-PFIZER INC-2012185566</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIP ARTHROPLASTY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EZETIMIBE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>FATIGUE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>OESOPHAGITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRIMARY HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD THYROID STIMULATING HORMONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040226</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GENOTROPIN</medicinalproduct>
        <drugdosagetext>0.5 MG, 1XDAY, 7INJECTIONS/WEEK</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070503</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRBESARTAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031002</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567831-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012125522</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COMPLEX REGIONAL PAIN SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>LIMB DISCOMFORT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>40 MG, 3X/DAY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugauthorizationnumb>021446</drugauthorizationnumb>
        <drugindication>BURNING SENSATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567832-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-PFIZER INC-2012180060</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>53</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>62</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENTEROCOLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>IRINOTECAN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>020571</drugauthorizationnumb>
        <drugdosagetext>313 MG, CYCLIC ONCE IN 2WEEKS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>696 MG, CYCLIC ONCE IN 2WEEKS</drugdosagetext>
        <drugadministrationroute>040</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLINDAMYCIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMPERAN TAB</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEPRENONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TPN ELECTROLYTES IN PLASTIC CONTAINER</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OXALIPLATIN</medicinalproduct>
        <drugdosagetext>148 MG, CYCLIC ONCE IN 2WEEKS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYFAST</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120723</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUOROURACIL</medicinalproduct>
        <drugdosagetext>4176 MG, CYCLIC, ONCE IN 2WEEKS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN TANNATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFEPIME HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUMIN HUMAN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LEVOLEUCOVORIN CALCIUM</medicinalproduct>
        <drugdosagetext>348 MG, CYCLIC ONCE IN 2WEEKS</drugdosagetext>
        <drugadministrationroute>041</drugadministrationroute>
        <drugindication>PANCREATIC CARCINOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYPREXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>13</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELNEOPA NO.1</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEFAZOLIN SODIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHYSIO 35</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567833-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012177856</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugauthorizationnumb>020987</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugauthorizationnumb>017783</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567834-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012121503</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.098</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugbatchnumb>59572041000</drugbatchnumb>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567835-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012162061</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>181</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOPTYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL</medicinalproduct>
        <drugdosagetext>1.25 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SINUS TACHYCARDIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120620</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROGOL</medicinalproduct>
        <drugdosagetext>1 SACHET, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLIZINE</medicinalproduct>
        <drugdosagetext>30 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AXITINIB</medicinalproduct>
        <drugauthorizationnumb>202324</drugauthorizationnumb>
        <drugdosagetext>5 MG, CYCLIC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
        <drugtreatmentduration>32</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567836-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-PFIZER INC-2012184385</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>21</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PHYSICAL ASSAULT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL INTERACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALCOHOL POISONING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VARENICLINE</medicinalproduct>
        <drugauthorizationnumb>021928</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SMOKING CESSATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567837-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012177950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED DRIVING ABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugauthorizationnumb>020998</drugauthorizationnumb>
        <drugdosagetext>200 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090806</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567838-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ROCHE-1080796</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENTOLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XOLAIR</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ASTHMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567839-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-1093796</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID NEOPLASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LARYNGEAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIO-RESPIRATORY ARREST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUNG DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSORIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORENCIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROSYN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567840-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-AMGEN-USANI2012047397</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>2.384</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugdosagetext>30 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120616</drugenddate>
        <drugtreatmentduration>219</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOMID</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111115</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120330</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETANERCEPT</medicinalproduct>
        <drugdosagetext>50 MG, QWK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELAFEN</medicinalproduct>
        <drugdosagetext>2000 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111119</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111203</drugenddate>
        <drugtreatmentduration>23</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugdosagetext>1000 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>SINUSITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>325 MG, BID</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>UTERINE HYPERTONUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>42</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugdosagetext>250 MG, QWK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120629</drugenddate>
        <drugtreatmentduration>226</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBUTALINE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
        <drugtreatmentduration>18</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAMETHASONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120604</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120329</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>DYSPEPSIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PREMATURE LABOUR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHORIONIC GONADOTROPIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>IN VITRO FERTILISATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111123</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>247</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>500 MG, BID</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>VAGINITIS BACTERIAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1 MG, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>118</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugindication>PNEUMONIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120402</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
        <drugadministrationroute>064</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120330</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567841-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ASTRAZENECA-2012SE51329</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>26483</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BUSPAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BRILINTA</medicinalproduct>
        <drugauthorizationnumb>022433</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHOLESTEROLAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567842-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007338</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>36</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOGLYCAEMIC UNCONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN R</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugauthorizationnumb>021368</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIAGRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMULIN N</medicinalproduct>
        <drugdosagetext>UNK, BID</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567843-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1204USA03122</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMORAL NECK FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL SEPTAL DEFECT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEDATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW TURNOVER OSTEOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UTERINE LEIOMYOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEURALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RADIUS FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA SUPRAVENTRICULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION POSTOPERATIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NUCHAL RIGIDITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugindication>INFECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050512</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060808</drugenddate>
        <drugtreatmentduration>454</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEXOFENADINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>60 MG, Q12H</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071022</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080818</drugenddate>
        <drugtreatmentduration>302</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051024</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051122</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, QM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090831</drugenddate>
        <drugtreatmentduration>396</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080803</drugenddate>
        <drugtreatmentduration>162</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPENIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050831</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080218</drugenddate>
        <drugtreatmentduration>902</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20051129</drugenddate>
        <drugtreatmentduration>15</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567844-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-ASTRAZENECA-2012SE32146</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>82</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERURICAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTIST</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOUGHMAC E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GASTRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLIVAS</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111024</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICHLORMETHIAZIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>OEDEMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567845-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-VERTEX PHARMACEUTICALS INC.-AE-2012-010719</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>70</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120607</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADERM</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMENDIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERISLON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOXONIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TALION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TELAVIC (TELAPREVIR)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120711</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIRUDOID LOTION</medicinalproduct>
        <drugadministrationroute>062</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLACET F</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120716</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120530</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUFAST</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALBLOCK</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567846-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0849830-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>138.47</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>5 MG MWFS, 2.5MG T,T S</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567847-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110914</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854683-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugdosagetext>AS REQUIRED TWICE A WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGUARD</medicinalproduct>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>HERPES ZOSTER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567848-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US016229</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>88</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECAL INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MACULAR DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 DF, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENEFIBER W/ WHEAT DEXTRIN</medicinalproduct>
        <drugbatchnumb>10107322</drugbatchnumb>
        <drugdosagetext>3 TSP, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG THERAPY NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DRUG THERAPY NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIAC THERAPY</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DRUG THERAPY NOS</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE SODIUM</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567849-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CHPA2012US012622</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPENDENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYLEPHRINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK, UNK</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19770101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567850-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854680-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567851-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856901-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110920</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567852-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110915</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855016-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110908</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORAL CONTRACEPTIVE NOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567853-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111106</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871539-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567854-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111104</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871536-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567855-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>PILLS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567856-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0871998-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLECAINIDE ACETATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567857-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0881597-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567858-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351592USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLAN B ONE-STEP</medicinalproduct>
        <drugauthorizationnumb>021998</drugauthorizationnumb>
        <drugdosagetext>1.5 MILLIGRAM;</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POST COITAL CONTRACEPTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567859-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-VERTEX PHARMACEUTICALS INC.-000000000000000656</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INCIVO (TELAPREVIR)</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGINTERFERON ALFA-2A</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVO (TELAPREVIR)</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugdosagetext>DOSAGE FORM: TABLET</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120425</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567860-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-010354</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOOT OPERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120720</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567861-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-010601</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19800101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EQUATE ALLERGY RELIEF</medicinalproduct>
        <drugindication>RASH PRURITIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PLACEBO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
        <drugindication>ROSACEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VX-950</medicinalproduct>
        <drugauthorizationnumb>71832</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120322</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAS-X</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOLD BOND INTENSIVE HEALING CREAM</medicinalproduct>
        <drugindication>RASH PRURITIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120711</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567862-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059073</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>10 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567863-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120622</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-14290084</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PHOTOSENSITIVITY REACTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugbatchnumb>IM46990A</drugbatchnumb>
        <drugauthorizationnumb>020757</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>1 DOSAGE FORM= 54 UNITS ALSO ON 64UNITS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
        <drugdosagetext>1 DOSAGE FORM= 2.5/500MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugauthorizationnumb>020357</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugdosagetext>2TAB IN NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567864-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110810</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15961907</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567865-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110906</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-15967342</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
        <drugdosagetext>1 DF-25 MG/500 MG.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567866-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16120719</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>66</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL SENSATION IN EYE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
        <drugdosagetext>THERAPY FROM:20 YEARS AGO  1DF:2 TABS/D INTERRUPTED AND RESTARTED ON 29SEP11</drugdosagetext>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567867-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16280505</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>71</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugbatchnumb>1F208A</drugbatchnumb>
        <drugdosagetext>1DF:10 UNITS INJ SOLUTION 100 IN/ML</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567868-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16565756</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567869-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BRISTOL-MYERS SQUIBB COMPANY-16726036</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugauthorizationnumb>021178</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567870-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-PFIZER INC-2012183801</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBRAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>016793</drugauthorizationnumb>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugauthorizationnumb>016793</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110618</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugdosagetext>6 MG, UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110618</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110618</drugenddate>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugindication>MYELODYSPLASTIC SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567871-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012179039</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.195</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INOTUZUMAB OZOGAMICIN</medicinalproduct>
        <drugdosagetext>1.536 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CISPLATIN</medicinalproduct>
        <drugauthorizationnumb>091062</drugauthorizationnumb>
        <drugdosagetext>96 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120722</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugdosagetext>720 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GEMCITABINE HYDROCHLORIDE</medicinalproduct>
        <drugauthorizationnumb>200145</drugauthorizationnumb>
        <drugdosagetext>960 MG, UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE ACETATE</medicinalproduct>
        <drugdosagetext>40 MG, 1X/DAY, FOR 4 DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICODONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567872-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012164233</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOFT TISSUE INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110615</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567873-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-US-WYE-H17496110</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.4</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HALLUCINATIONS, MIXED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>50 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAPINEUZUMAB</medicinalproduct>
        <drugdosagetext>1.0 MG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100610</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100610</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugauthorizationnumb>011153</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANTIINFLAMMATORY THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100728</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAPINEUZUMAB</medicinalproduct>
        <drugdosagetext>1.0 MG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101209</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>30 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAPINEUZUMAB</medicinalproduct>
        <drugdosagetext>1.0 MG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100318</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100318</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEDROL</medicinalproduct>
        <drugauthorizationnumb>011153</drugauthorizationnumb>
        <drugindication>ANTIALLERGIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugdosagetext>UNKNOWN DOSE ONCE DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BAPINEUZUMAB</medicinalproduct>
        <drugdosagetext>1.0 MG/KG, SINGLE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100909</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100909</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>INFLAMMATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100727</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100727</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBATRIN</medicinalproduct>
        <drugdosagetext>500 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19990101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugdosagetext>15 MG, UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>ANTIALLERGIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GALANTAMINE HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>24 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567874-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012171580</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INTERSTITIAL LUNG DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ADENOCARCINOMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567875-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012023753</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>43.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEBRILE NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>091063</drugauthorizationnumb>
        <drugdosagetext>305 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>705 MG, CYCLIC, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NEOPLASM MALIGNANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111230</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>4 MG, ONE TABLET BID AFTER CHEMO, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugdosagetext>8 MG, UP TO 2 PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugdosagetext>500 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONVULSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>091540</drugauthorizationnumb>
        <drugdosagetext>280 MG, CYCLIC, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111230</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PACLITAXEL</medicinalproduct>
        <drugauthorizationnumb>091540</drugauthorizationnumb>
        <drugdosagetext>195 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CARBOPLATIN</medicinalproduct>
        <drugauthorizationnumb>091063</drugauthorizationnumb>
        <drugdosagetext>582 MG, CYCLIC, EVERY 3 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111230</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEVACIZUMAB</medicinalproduct>
        <drugdosagetext>645 MG, ONCE</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120125</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugdosagetext>5 MG, 1 PRIOR TO CHEMO, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>50 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>ANTIPLATELET THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG, THREE TIMES A DAY, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE</medicinalproduct>
        <drugdosagetext>25 MG, 1X/DAY, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ABDOMINAL DISCOMFORT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>200 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111229</drugenddate>
        <drugtreatmentduration>157</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>5/500, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110614</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567876-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-PFIZER INC-2012091972</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>48</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTIOUS PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110818</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOVICOLON</medicinalproduct>
        <drugdosagetext>1 DF, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EBASTINE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110515</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567877-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IE-PFIZER INC-2011284213</companynumb>
    <primarysource>
      <reportercountry>IRELAND</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>49</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD ALBUMIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERICARDIAL EFFUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLEURAL EFFUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARACETAMOL</medicinalproduct>
        <drugdosagetext>1 G, AS NEEDED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANALGESIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SMALL CELL LUNG CANCER METASTATIC</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111012</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
        <drugtreatmentduration>55</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567878-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012184466</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.145</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110528</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>21110</drugauthorizationnumb>
        <drugdosagetext>4 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST TRANSPLANT REJECTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110525</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEREX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PHOSPHATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIROLIMUS</medicinalproduct>
        <drugauthorizationnumb>021110</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110530</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567879-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-PFIZER INC-2012104427</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>81</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPROTEINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>8 MG, 3X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugdosagetext>10 MG, 1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120219</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE</medicinalproduct>
        <drugdosagetext>1X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BONE PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-SMALL CELL LUNG CANCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120323</drugenddate>
        <drugtreatmentduration>127</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRIZOTINIB</medicinalproduct>
        <drugauthorizationnumb>202570</drugauthorizationnumb>
        <drugdosagetext>250 MG, 2X/DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
        <drugtreatmentduration>16</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOCLOPRAMIDE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON HYDROCHLORIDE</medicinalproduct>
        <drugindication>VOMITING</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567880-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-PFIZER INC-2012187288</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS BRADYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TROPONIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PDGFRA</medicinalproduct>
        <drugdosagetext>1125 MG, OTHER</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120621</drugenddate>
        <drugtreatmentduration>113</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HCL</medicinalproduct>
        <drugauthorizationnumb>50467</drugauthorizationnumb>
        <drugdosagetext>145 MG, OTHER</drugdosagetext>
        <drugindication>SARCOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120503</drugenddate>
        <drugtreatmentduration>64</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PDGFRA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567881-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-FRI-1000031136</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPLICATED FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATARAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567882-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DK-BAXTER-2012BAX013429</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD S/D</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>017</drugadministrationroute>
        <drugindication>NARCOLEPSY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GAMMAGARD S/D</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>OFF LABEL USE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567883-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NZ-BAXTER-2012BAX013075</companynumb>
    <primarysource>
      <reportercountry>NEW ZEALAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 2.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EXTRANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021321</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567884-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PL-BAXTER-2012BAX012799</companynumb>
    <primarysource>
      <reportercountry>POLAND</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL PD-2 W/ DEXTROSE 4.25%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567885-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX013269</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CARCINOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567886-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX011558</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120710</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567887-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012854</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL LOW CALCIUM W/ DEXTROSE 1.5%</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIANEAL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>017512</drugauthorizationnumb>
        <drugadministrationroute>033</drugadministrationroute>
        <drugindication>PERITONEAL DIALYSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567888-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2012BAX012950</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENCEPHALOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCALCAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS NOS</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>040745</drugauthorizationnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugbatchnumb>A10A24/1001</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111002</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DECADRON PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567889-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-BAXTER-2011BH016538</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABT-263</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101214</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOZOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>40745</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110113</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101118</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110407</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110311</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110311</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101114</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101128</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110211</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CANDESARTAN CILEXETIL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUCONAZOLE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>ANTIFUNGAL PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL SULATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 PUFF</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101103</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101114</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>2 TABLETS</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYCLOPHOSPHAMIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>040745</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGFILGRASTIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110408</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110408</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>NAUSEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RITUXIMAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110308</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110308</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALUMINIUM CHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>061</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABT-263</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101118</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101120</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLUDARABINE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN,UNKNOWN</drugbatchnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101119</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101119</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDANSETRON</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110208</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>PREMEDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101115</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110111</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110111</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE PHOSPHATE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110405</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110405</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPERAMIDE HCL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>1 TABLET</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 CC</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN CALCIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567890-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-TEVA-351558USA</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC MASS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TREANDA</medicinalproduct>
        <drugauthorizationnumb>022249</drugauthorizationnumb>
        <drugdosagetext>Q 4 WEEKS</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>CHRONIC LYMPHOCYTIC LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120516</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567891-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059055</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CLOSTRIDIAL INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
        <drugtreatmentduration>63</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567892-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-CELGENEUS-163-21880-12073243</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>THYROID CANCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>THALOMID</medicinalproduct>
        <drugauthorizationnumb>020785</drugauthorizationnumb>
        <drugdosagetext>200 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PLASMACYTOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIAXIN</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>25 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MULTIPLE MYELOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20091201</drugenddate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567893-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0058973</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CEREBROVASCULAR ACCIDENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRUVADA</medicinalproduct>
        <drugauthorizationnumb>021752</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISENTRESS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567894-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-FRI-1000036632</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SPUTUM INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARKINSONISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110823</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEMENTIA ALZHEIMER'S TYPE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110810</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MEMANTINE HCL</medicinalproduct>
        <drugauthorizationnumb>021487</drugauthorizationnumb>
        <drugdosagetext>15 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCOSOLVAN</medicinalproduct>
        <drugdosagetext>45 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SPUTUM INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110827</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAXOBERON</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CONSTIPATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110927</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567895-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-FRI-1000036934</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTENTIONAL OVERDOSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG ABUSE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ESCITALOPRAM</medicinalproduct>
        <drugauthorizationnumb>21323</drugauthorizationnumb>
        <drugdosagetext>1 POSOLOGICAL UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LENDORMIN</medicinalproduct>
        <drugdosagetext>1 POSOLOGICAL UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>OLANZAPINE</medicinalproduct>
        <drugdosagetext>1 POSOLOGICAL UNIT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MINIAS</medicinalproduct>
        <drugdosagetext>150 POSOLOGICAL UNITS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SUICIDE ATTEMPT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567896-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12053028</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NON-HODGKIN'S LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110420</drugenddate>
        <drugtreatmentduration>68</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567897-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PE-PFIZER INC-2012184570</companynumb>
    <primarysource>
      <reportercountry>PERU</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MENINGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugauthorizationnumb>020597</drugauthorizationnumb>
        <drugadministrationroute>047</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567898-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-PFIZER INC-2012126190</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>20</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEVICE FAILURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPIPEN</medicinalproduct>
        <drugauthorizationnumb>019430</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ANAPHYLACTIC SHOCK</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567899-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>FR-PFIZER INC-2012182541</companynumb>
    <primarysource>
      <reportercountry>FRANCE</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOLESTASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CORDARONE</medicinalproduct>
        <drugauthorizationnumb>18972</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120521</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLAVULANATE POTASSIUM</medicinalproduct>
        <drugdosagetext>5 GRAM(S);3 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120605</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIDAZOLAM HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120525</drugenddate>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYVOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
        <drugtreatmentduration>9</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugdosagetext>1 GRAM(S);3 TIMES A DAY</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVENOX</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METRONIDAZOLE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120609</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM TARTRATE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120529</drugenddate>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMACTANE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120606</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CEFTRIAXONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120519</drugenddate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567900-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-PFIZER INC-2011178523</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>76</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>63</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ACUTE CORONARY SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BOSENTAN</medicinalproduct>
        <drugdosagetext>125 MG, 2X/DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110413</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVATIO</medicinalproduct>
        <drugauthorizationnumb>021845</drugauthorizationnumb>
        <drugdosagetext>20 MG, 3X/DAY</drugdosagetext>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
        <drugtreatmentduration>50</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567901-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-OPTIMER-20120099</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DIFICID</medicinalproduct>
        <drugauthorizationnumb>201699</drugauthorizationnumb>
        <drugdosagetext>200 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CLOSTRIDIUM DIFFICILE COLITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567902-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2010SP056198</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGAMENT SPRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERCOAGULATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMINS (UNSPECIFIED)</medicinalproduct>
        <drugdosagetext>UNK UNK, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050413</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050529</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>DEEP VEIN THROMBOSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567903-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-MILLENNIUM PHARMACEUTICALS, INC.-2012-05242</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>17</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>42.7</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL SENSORY NEUROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DOXORUBICIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>50 MG/M2, CYCLIC</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYTARABINE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG/M2, CYCLIC</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ETOPOSIDE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugdosagetext>100 MG/M2, CYCLIC</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
        <drugtreatmentduration>36</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VELCADE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>021602</drugauthorizationnumb>
        <drugdosagetext>1.3 MG/M2, CYCLIC</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120717</drugenddate>
        <drugtreatmentduration>39</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DAUNORUBICIN HCL</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>ACUTE MYELOID LEUKAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567904-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16455BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567905-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-13702NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HICCUPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>EPINASTINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567906-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120523</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AT-TEVA-339881ISR</companynumb>
    <primarysource>
      <reportercountry>AUSTRIA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>83</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPONATRAEMIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111130</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugauthorizationnumb>075776</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111205</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MILLIGRAM;</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111212</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RISPERDAL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NACL KAPAELN</medicinalproduct>
        <drugdosagetext>1/0/2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOMINAL FORTE</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOLAXOLE (SODIUM BICARBONATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MAC</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111203</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NACL KAPAELN</medicinalproduct>
        <drugdosagetext>2/2/2</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111205</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567907-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059064</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567908-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17472BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRADJENTA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>201280</drugauthorizationnumb>
        <drugdosagetext>5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>TYPE 2 DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567909-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-17008BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567910-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-12746NB</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RAYNAUD'S PHENOMENON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIXED CONNECTIVE TISSUE DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NR</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120423</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567911-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16441BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATOCRIT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CEREBROVASCULAR ACCIDENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567912-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16682BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>2.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugdosagetext>12.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567913-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16997BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567914-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ASTRAZENECA-2012SE53245</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>22291</patientonsetage>
      <patientonsetageunit>804</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugauthorizationnumb>021153</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERCHLORHYDRIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120706</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567915-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CO-ROCHE-1089001</companynumb>
    <primarysource>
      <reportercountry>COLOMBIA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>KIDNEY TRANSPLANT REJECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELLCEPT</medicinalproduct>
        <drugauthorizationnumb>050722</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RENAL TRANSPLANT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070623</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567916-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7045871</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATOTOXICITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110126</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110302</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567917-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7151154</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLOW SPEECH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEMENTIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU003535</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567918-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120728</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7140121</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>172</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJECTION SITE ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM PILLS</medicinalproduct>
        <drugindication>BLOOD POTASSIUM DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugindication>URINARY INCONTINENCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugbatchnumb>AU002476</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110726</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>OEDEMA PERIPHERAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567919-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567920-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110811</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844473-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN,01237AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN,01237AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567921-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857275-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567922-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857117-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567923-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>BR-ROCHE-1061599</companynumb>
    <primarysource>
      <reportercountry>BRAZIL</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RED BLOOD CELL SEDIMENTATION RATE ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALAT</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110503</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111117</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN W/ CODEINE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567924-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CN-ROCHE-1095695</companynumb>
    <primarysource>
      <reportercountry>CHINA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>41</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>IMPAIRED HEALING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VASCULAR GRAFT COMPLICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPERGILLOSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METHYLPREDNISOLONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TACROLIMUS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MYCOPHENOLATE MOFETIL</medicinalproduct>
        <drugauthorizationnumb>050759</drugauthorizationnumb>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ANTI-THYMOCYTE GLOBULIN NOS</medicinalproduct>
        <drugindication>IMMUNOSUPPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567925-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-ROCHE-1088382</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTEMRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567926-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882862-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567927-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883262-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567928-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856926-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>NAUSEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567929-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856936-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567930-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844589-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTC PAIN RELIEVER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567931-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567932-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844512-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOCAL SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETHANECHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRAPIPATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567933-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883063-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111206</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567934-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882861-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567935-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856998-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567936-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882948-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/12.5, DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567937-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844511-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567938-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844635-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLORA CON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETOBOLAC</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567939-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844528-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567940-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844485-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567941-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857238-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN - 2 TYPES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567942-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844649-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE ATROPHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVIDART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567943-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVOXYL</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567944-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844531-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110803</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567945-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883058-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567946-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7151155</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WOUND SECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CALCULUS BLADDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120528</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567947-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-US-EMD SERONO, INC.-7053197</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MULTIPLE SCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECUBITUS ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBIF</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061009</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567948-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844489-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.524</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110802</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567949-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567950-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868203-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BABY ASA CHEWABLE</medicinalproduct>
        <drugdosagetext>WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567951-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857476-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567952-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857809-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567953-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876487-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567954-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868267-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567955-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857588-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567956-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868155-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CPAP MACHINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHYLPHENIDATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111025</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567957-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857658-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567958-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877830-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINGKO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567959-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876888-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111116</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567960-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876501-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567961-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVALIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567962-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG PRESCRIBING ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACANB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>250 MG</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567963-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876679-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567964-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876448-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>45</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567965-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843283-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIMADEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMPERINE/HCTZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACYCLOVAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567966-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877062-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110923</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567967-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843289-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567968-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843646-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>3-4 TABS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugdosagetext>OCCASSIONAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT 500 MG TAB -FOR A BRIEF TIME</drugdosagetext>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIANXIETY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>REDUCED TO 500 MG X 2 AT HS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY WITH NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567969-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877296-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567970-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843668-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567971-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110829</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850553-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.21</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKEN AT 1800</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110730</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110728</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110730</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567972-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843358-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567973-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877834-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111122</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567974-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843674-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG EVERY BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567975-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2007US05483</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PROTEINURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VENA CAVA THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IMMUNODEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TRICUSPID VALVE INCOMPETENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRESYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MULTIPLE MYELOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUPERIOR VENA CAVA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC ACIDOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FOOT DEFORMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOFASCIAL PAIN SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROENTERITIS BACTERIAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYOCARDIAL INFARCTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUMOUR PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AZOTAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CREATININE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COMPRESSION FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOGAMMAGLOBULINAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOKALAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOLYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHOPNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TUBULOINTERSTITIAL NEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEONECROSIS OF JAW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIGHT CHAIN ANALYSIS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF FOREIGN BODY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LUMBAR RADICULOPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE ACUTE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRODUODENITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL HERPES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERLIPIDAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STREPTOCOCCAL SEPSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL SPASM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ODYNOPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LEUKOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL TUBULAR NECROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST MASS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL CANDIDIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL STENOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BREAST TENDERNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOCYTOPENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULONEPHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLOMERULOSCLEROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LACTOSE INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7.5 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT                            /00909301/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECADRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORHEXIDINE GLUCONATE</medicinalproduct>
        <drugdosagetext>15 ML, Q12H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERIDEX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHENHYDRAMINE HCL</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADRIAMYCIN PFS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMAGEN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugdosagetext>40 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEPTRA DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugdosagetext>300 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOFRAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FILGRASTIM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.5 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINCRISTINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AREDIA</medicinalproduct>
        <drugauthorizationnumb>020036</drugauthorizationnumb>
        <drugdosagetext>90 MG, QMO</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugdosagetext>2.5 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM SULFATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN</medicinalproduct>
        <drugdosagetext>25 MG, Q6H</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTAZOCINE LACTATE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DURAGESIC-100</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAQUIN</medicinalproduct>
        <drugdosagetext>500 MG, DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NYSTATIN</medicinalproduct>
        <drugdosagetext>5 ML</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>20 MG, PRN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugdosagetext>650 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKERAN</medicinalproduct>
        <drugdosagetext>172 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOCUSATE</medicinalproduct>
        <drugdosagetext>100 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZOMETA</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20011201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugdosagetext>1 MG, QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOVIRAX</medicinalproduct>
        <drugdosagetext>200 MG, Q12H</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENOKOT                                 /UNK/</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTERFERON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugdosagetext>5 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATROPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMETHICONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugdosagetext>30 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPAZINE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAGYL</medicinalproduct>
        <drugdosagetext>250 MG, TID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL ^PFIZER WARNER-LAMBERT^</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICYCLOMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567976-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0854275-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COCU 10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567977-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111101</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0855525-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LATANOPROST</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugdosagetext>37.5/25 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FEMHRT</medicinalproduct>
        <drugdosagetext>0.5 MG/1.5 MCG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567978-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868064-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPOXLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>PATCH</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567979-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883055-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567980-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883037-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PO QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRICAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567981-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883091-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111211</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567982-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1/2 TAB PO QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567983-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882928-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ULCER MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567984-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857196-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.794</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugdosagetext>1 TABLET EACH BEFORE BREAKFAST + SUPPER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567985-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857552-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567986-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882952-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.646</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567987-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882713-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>750 MG DAILY AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567988-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857468-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>181.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567989-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110903</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857239-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AUTOIMMUNE THYROIDITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEE OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT B6</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567990-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882683-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PANIC ATTACK</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNG MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREATHING INHALER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BREATHING TREATMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEART MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567991-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857277-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567992-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857596-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567993-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857226-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG ADMINISTRATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL XR 10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZEGERID OTC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110915</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RUTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567994-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567995-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868213-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAIN PUMP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567996-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876491-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567997-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110924</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857482-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567998-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0883259-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8567999-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857659-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENESTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568000-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868059-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568001-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857488-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568002-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111212</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882866-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>BLOOD IRON</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568003-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111023</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868196-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSTATE MEDICATION</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568004-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857546-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN.</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568005-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868077-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>A COMPOUND MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568006-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868087-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568007-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857645-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSLOFENAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>X 2 TABS AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATOMIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKE ONE PILL - NOT TWO PILLS -500 MG EA</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>Q DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568008-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877831-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568009-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867948-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568010-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568011-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>75</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATROL</medicinalproduct>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568012-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877224-00</companynumb>
    <primarysource>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568013-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877186-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TACHYCARDIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CONJUGATED ESTROGENS</medicinalproduct>
        <drugindication>HYSTERECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568014-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877091-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568015-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876623-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568016-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868210-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568017-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876887-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568018-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868083-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568019-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876576-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC MED FOR PROVIGIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FOR ABOUT ONE WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MED FOR PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSAARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568020-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867967-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568021-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876278-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN IMMUNE SUPPORT SUPPLEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INITIAL DOSE-X2 500MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111118</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568022-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877808-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROXATRAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111020</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568023-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568024-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876651-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORAGEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568025-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868056-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568026-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868199-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568027-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877835-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568028-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111025</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868062-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER DINNER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568029-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111021</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>JOINT SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>06234AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>06234AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111018</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>JOINT SWELLING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568030-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843345-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN GALLSTONE MEDICATION</medicinalproduct>
        <drugindication>CHOLELITHIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568031-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868205-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568032-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876890-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568033-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843681-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>UNKNOWN MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>UNKNOWN MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAVELLA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BONE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568034-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876630-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568035-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>147.55</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568036-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868204-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568037-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877098-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568038-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111118</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876714-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.49</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568039-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843336-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568040-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876898-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIPROFLOXACIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568041-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843343-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DIABETES MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568042-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877793-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ONE DAILY, WITH NIASPAN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568043-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110804</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843648-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568044-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877206-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568045-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843612-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110729</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568046-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA014060</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>AGITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOUTH ULCERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEJA VU</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PUSTULE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEREALISATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568047-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2011BE100221</companynumb>
    <primarysource>
      <reportercountry>BELGIUM</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE RIGIDITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GRAND MAL CONVULSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONFUSIONAL STATE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONVULSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>GILENYA</medicinalproduct>
        <drugauthorizationnumb>022527</drugauthorizationnumb>
        <drugdosagetext>0.5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>RELAPSING-REMITTING MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110809</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugdosagetext>100 MG, QID</drugdosagetext>
        <drugindication>GRAND MAL CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PHENYTOIN SODIUM</medicinalproduct>
        <drugdosagetext>300MG TO 400 MG, UNK</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568048-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012DE066146</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>OVERLAP SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHRONIC GRAFT VERSUS HOST DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CERTICAN</medicinalproduct>
        <drugauthorizationnumb>021560</drugauthorizationnumb>
        <drugdosagetext>0.75 MG, BID</drugdosagetext>
        <drugindication>PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568049-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857466-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568050-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882944-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568051-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857249-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110918</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110920</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568052-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINERAL TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568053-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844628-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>123.03</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568054-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844509-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTIM</medicinalproduct>
        <drugdosagetext>DAILIY, GEL</drugdosagetext>
        <drugadministrationroute>062</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568055-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110808</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0844724-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.254</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110805</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568056-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857245-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568057-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882858-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD LACTATE DEHYDROGENASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCLE RELAXANTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRIZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568058-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110923</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568059-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110926</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857649-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110922</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568060-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111026</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0868268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568061-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111020</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0867956-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568062-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0857798-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>56</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL W/HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110921</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568063-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850751-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568064-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.426</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALBUMIN URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568065-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12053025</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXAMETHASONE</medicinalproduct>
        <drugdosagetext>1.4286 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>065</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090430</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090901</drugenddate>
        <drugtreatmentduration>124</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568066-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876511-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568067-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843261-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110731</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568068-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568069-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843203-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ-10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568070-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876885-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AFTER DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568071-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953176-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120702</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568072-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843687-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLATEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568073-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955234-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568074-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953477-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD THINNER MEDICATION</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568075-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT AROUND 11:00 PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568076-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953927-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PACERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568077-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955281-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568078-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954529-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568079-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953895-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS PER DAY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568080-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>BEFORE BEDTIME AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568081-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954600-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120709</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE OR IMDUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568082-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843602-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>OCCASIONAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568083-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960441-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BIRTH CONTROL PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568084-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959746-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME FOR 1 MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 DURING THE DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568085-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959351-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568086-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959516-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568087-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954947-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYGEN</medicinalproduct>
        <drugdosagetext>24 HOURS A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 DOSE AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICINES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568088-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954155-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FOR SOME TIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568089-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959778-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 IN 1 DAY, IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568090-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843688-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS CORONARY ARTERY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568091-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568092-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955263-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN TO MANAGE FLUSHING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568093-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954532-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIETARY SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>CURRENT DOSE: 1000MG DOSE FOR ONE NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568094-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954492-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKING IT BETWEEN 7-8 PM</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568095-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953164-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.524</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISION BLURRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugdosagetext>DAILY. PATIENT SAYS FORGETS TO TAKE.</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120702</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568096-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954127-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568097-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953281-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.186</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120608</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORCET-HD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568098-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960054-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568099-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955782-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG INTOLERANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2- 500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568100-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959751-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568101-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, IN MORNING</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568102-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850749-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110825</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568103-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877849-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>ANTIBIOTIC PROPHYLAXIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568104-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953330-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568105-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850692-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING, AFTERNOON, AND BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568106-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850620-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568107-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953464-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS SOLAR STAR</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M10 POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE A DAY, NO LOT# AVAILABLE REPACKAGED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXALOT</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>BIPOLAR DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugindication>CROHN'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568108-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843453-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110729</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568109-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953166-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568110-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850684-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>135.75</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110824</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING FOR ONE WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110817</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110824</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugdosagetext>PILLS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHANTIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>LARGE DOSE - UNSPECIFIED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568111-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954056-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAWTHORN BERRY</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568112-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843293-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110720</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUVOX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/25MG, DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568113-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953586-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568114-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850733-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 WITH EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568115-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959529-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.278</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STOMACH PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568116-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN INSULIN</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>TWICE DAILY AS REQUIRED</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568117-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960547-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>20-30 MINUTES BEFORE TAKING NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568118-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960348-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568119-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843622-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED HYPERTENSION MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568120-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960432-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DAILY VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568121-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955262-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568122-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843672-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHIA PEPPER SUPPLEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568123-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953645-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568124-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954120-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKING WITH HIS DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568125-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110909</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850673-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLEEVAK</medicinalproduct>
        <drugindication>LEUKAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568126-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955227-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVAIR DISKUS 100/50</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOMICIN</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120707</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXIRON</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXIRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568127-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954152-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2X500MG IN AM AND 2X500MG AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE AM DOSE OF NIASPAN AND ADDITIONAL ASA AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568128-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953576-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AROUND 10:30 AT NIGHT</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568129-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954501-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTC SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568130-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953650-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1PILL-DOSE KNOWN TAKING IT BETWEEN 09-10 AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568131-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843683-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTIM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DULERA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568132-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955251-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568133-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953618-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKEN AT BEDTIME DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568134-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953919-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>4 PER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALACICLOVIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568135-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568136-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954108-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 IN 1 DAY, IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568137-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953899-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIDODERM</medicinalproduct>
        <drugdosagetext>APPLIED TO SKIN</drugdosagetext>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTOXIFYLLINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568138-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959728-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568139-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568140-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955240-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568141-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850683-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MILLIGRAM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBENECID + COLCHICINE</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESVERATROL SUPPLEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EACH NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568142-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955198-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.886</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FOLLICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 VERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568143-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954952-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MUSCLE FATIGUE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2 TABLETS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568144-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954365-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>4.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugindication>GENITAL HERPES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HOMEOPATHIC VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568145-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959764-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568146-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955298-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000IU EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>1000 MCG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CALCIUM INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568147-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956147-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.886</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568148-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120803</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-EISAI INC-E2090-01255-SPO-JP</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT ILLNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-DOPA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugauthorizationnumb>020789</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PARKINSON'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMTAN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568149-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876979-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568150-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843332-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568151-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL TENDERNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568152-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843356-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568153-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877358-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TWITCHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20081201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568154-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850515-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568155-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843503-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568156-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110901</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850745-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR PRIOR TO DINNER</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110816</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110816</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DUONEB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568157-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877229-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLEST OFF</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111119</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568158-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843623-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568159-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843179-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568160-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0876894-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>107.14</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIBENZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568161-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843699-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LISTLESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOLIZONE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>SINUSITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568162-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953475-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINETMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORICON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>INFLAMMATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFIN</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568163-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850522-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568164-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110831</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0850526-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568165-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0877842-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111028</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568166-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955324-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568167-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110913</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843266-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568168-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110803</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843732-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568169-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959747-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568170-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110802</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0843294-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568171-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090425</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-009507513-2008-185287-NL</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>IMPULSIVE BEHAVIOUR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugdosagetext>CONTINUING: NO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>UNK DF, UNK</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568172-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20090310</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>AU-009507513-2008-185491-NL</companynumb>
    <primarysource>
      <reportercountry>AUSTRALIA</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>20415</drugauthorizationnumb>
        <drugdosagetext>CONTINUING: NO</drugdosagetext>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080915</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20081015</drugenddate>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568173-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012057</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOOD ALTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>2 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>34</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>300 MG, UNK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>325 MG, PRN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>40 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>150 MG, BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DESOXIMETASONE</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>20 MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELOCON</medicinalproduct>
        <drugauthorizationnumb>019625</drugauthorizationnumb>
        <drugadministrationroute>061</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60 MG, BID</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugdosagetext>5/40, MG, QD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>50 MG, QD</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568174-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953171-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568175-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568176-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955374-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>EVERY WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>ONE EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568177-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956181-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTC GERD MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 IN 1 DAY, EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568178-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959768-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.364</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUNUMET GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120722</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568179-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955869-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568180-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959460-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568181-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954535-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568182-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954621-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568183-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960345-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugdosagetext>100/25</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568184-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956223-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>5MG 4 DAYS A WEEK, 2.5MG 3 DAYS A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMIODARONE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568185-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120706</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953920-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568186-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956923-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568187-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955761-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG 1 AT BEDTIME FOR ONE MONTH</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC SUPPLEMENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG 2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568188-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960059-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568189-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120517</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1-500 MG TABLET DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568190-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER NOT REPORTED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568191-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956217-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EDLUAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYLANTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568192-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959455-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOVANCE</medicinalproduct>
        <drugdosagetext>2 X TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CATAPRES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568193-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955788-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568194-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956071-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568195-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956373-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD GLUCOSE INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIBENZOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568196-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956541-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568197-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955361-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568198-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956258-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568199-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120720</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568200-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957165-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NOCTURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568201-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955428-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.794</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120705</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALTREX</medicinalproduct>
        <drugindication>ORAL HERPES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568202-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957580-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MECLIZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568203-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956695-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugdosagetext>1 TO 2 CAPSULES AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>TAKING IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHEWABLE ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKING AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODEINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568204-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957428-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568205-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958322-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568206-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958329-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120717</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568207-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955429-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>250/50</drugdosagetext>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>01323AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>7.5/300</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568208-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957429-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.296</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE W/ATORVASTATIN</medicinalproduct>
        <drugdosagetext>ONE IN ONE DAYS, 5/10</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568209-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958311-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.346</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568210-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959177-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568211-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958738-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG, AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>DEPRESSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120403</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568212-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960827-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568213-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957585-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568214-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961209-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568215-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957414-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANALGESIC ASTHMA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG, AT BED TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568216-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891291-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568217-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956790-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568218-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891261-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS NOT REPORTED</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568219-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957900-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG, AT BED TIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN Z</medicinalproduct>
        <drugdosagetext>5ML, ONE DROP IN EACH EYE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>134 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 UNITS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG HALF A TABLET TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTROVALE</medicinalproduct>
        <drugindication>ORAL CONTRACEPTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>12.5 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568220-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959771-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIVALPROEX SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568221-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955882-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGEUSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120706</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITHROMYCIN</medicinalproduct>
        <drugindication>COUGH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVASTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568222-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955412-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GALLBLADDER PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>PRN TWICE PER WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugdosagetext>500/20 MG AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120614</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>PRN TWICE PER WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568223-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954498-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO CU 10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C + E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568224-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012664</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>VOCAL CORD PARALYSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REBETOL</medicinalproduct>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PEG-INTRON</medicinalproduct>
        <drugdosagetext>DAILY DOSAGE UNKNOWN</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568225-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000208</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RESPIRATORY FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC ARREST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568226-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2009-189370-NL</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EPICONDYLITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCIATICA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD ALKALINE PHOSPHATASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHTMARE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLANTAR FASCIITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEEP VEIN THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE STRAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PHLEBITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OSTEOARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONJUNCTIVITIS ALLERGIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARPAL TUNNEL SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ACROCHORDON</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OVARIAN CYST RUPTURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BIRTH MARK</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>DOSE TEXT: 3 WEEKS EVERY MONTH, CONTINUING: NO</drugdosagetext>
        <drugadministrationroute>067</drugadministrationroute>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20061201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>50 ?G, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOITRE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugdosagetext>10 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROVENTIL</medicinalproduct>
        <drugdosagetext>UNK UNK, PRN</drugdosagetext>
        <drugindication>BRONCHITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568227-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956145-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568228-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955673-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLYCOSYLATED HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>100 MG EVERY MORNING AND AT BEDTIME</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568229-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOKING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568230-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955915-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>100 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568231-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956807-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>?MG AT BEDTIME, 20 MIN PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568232-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956027-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1/2 TABLET</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568233-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955781-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568234-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120714</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956197-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120704</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED DIABETES MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HYPERTENSION MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568235-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955866-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SEXUAL DYSFUNCTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONISAMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY INJECTIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568236-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955357-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568237-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956213-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKING IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568238-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957587-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.886</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN BP MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN DIABETES MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568239-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120708</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954027-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568240-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957582-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568241-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956144-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568242-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120709</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0954464-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERYDAY WITH DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1000MG-HALF TABLET, TWICE A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120623</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568243-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956488-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568244-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956935-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568245-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY DAY PRIOR TO DINNER TIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568246-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120715</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956186-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568247-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957285-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PERIPHERAL VASCULAR DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120703</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CILOSTAZOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>VARICOSE VEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120716</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568248-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959756-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568249-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120628</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568250-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568251-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957949-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568252-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956614-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120713</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568253-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120711</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>117.13</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UPPER-AIRWAY COUGH SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN-D</medicinalproduct>
        <drugindication>UPPER-AIRWAY COUGH SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568254-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956220-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568255-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568256-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RHEUMATOID ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANKLE FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FOR 4 TO 5 WEEKS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugdosagetext>5 MG PER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABLET IN AM AND 1 IN PM</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>1 X A WEEK ON SUNDAY MORNINGS 20MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM SILVER FOR MEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568257-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958668-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.836</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568258-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957244-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>500/20MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568259-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MV</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>HALF OF A 500MG TABLET 2 TIMES A DAY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH THE 250MG DOSE OF NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568260-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-BAYER-2012-078471</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>43</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BETASERON</medicinalproduct>
        <drugdosagetext>0.3 MG, QOD</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>MULTIPLE SCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568261-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957297-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568262-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956251-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENTAVIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ELIGARD</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PROSTATE CANCER</drugindication>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568263-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957562-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568264-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960746-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURE THYROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568265-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568266-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957314-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568267-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960598-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568268-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955370-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TERMINAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568269-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956963-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568270-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959081-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568271-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959259-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120714</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>1000 IU EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568272-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955863-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568273-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957250-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BIRTH CONTROL PILLS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568274-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958337-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DURING THE DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568275-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959179-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568276-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953158-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.934</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ER,  BEFORE GOING TO BED AROUND 10:30 PM</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568277-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955894-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568278-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957153-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120715</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568279-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568280-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890820-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CORTISOL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568281-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120712</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955711-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568282-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952847-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568283-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958730-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568284-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957128-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568285-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958943-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN DRUG</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568286-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961312-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STRESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120723</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568287-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957330-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>ONE TEASPOON DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TEST ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120710</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568288-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961328-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120726</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568289-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960979-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568290-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0955851-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568291-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.382</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugdosagetext>WITH VITAMIN D3</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568292-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934302-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568293-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934880-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugdosagetext>50MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120512</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>135MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>12.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568294-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934588-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568295-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961641-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOMETASONE FUROATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY NS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOCONAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE A DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568296-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957898-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EXOSTOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568297-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSSTASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>PRN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568298-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120721</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLSTOFF</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT BEDTIME</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568299-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956141-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568300-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891304-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568301-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958354-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568302-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957262-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568303-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958364-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568304-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932512-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568305-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958327-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568306-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0953160-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG X 2 TABLETS</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120627</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568307-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958330-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120714</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION FOR COLON HEALTH</medicinalproduct>
        <drugindication>GASTROINTESTINAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568308-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932862-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMIPRAMINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXCEDRIN (MIGRAINE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugdosagetext>FIVE DAYS PER WEEK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568309-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891303-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRREVASTAIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACHL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOW DOSE ENTERIC COATED ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE DOSE OF NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EARLY IN THE DAY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568310-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932812-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER SUPPER</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568311-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932709-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568312-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891428-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PERSONALITY CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20/25MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PARORETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568313-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891396-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG - AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568314-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958742-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568315-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568316-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIAPSAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568317-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933762-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>800MG AFTER DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568318-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961131-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568319-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891641-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>NOT REPORTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568320-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932887-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568321-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932866-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111230</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugdosagetext>1.65% TOPICAL</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>2GM DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568322-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960985-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568323-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934220-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568324-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891486-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECLINED LONG LIST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568325-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120507</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568326-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933391-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568327-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959254-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/12.5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120624</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568328-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934151-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN NASAL SPRAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568329-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934543-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG, EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568330-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933769-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN 70/30</medicinalproduct>
        <drugdosagetext>70/30 INSULIN DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN R</medicinalproduct>
        <drugdosagetext>INSULIN ON SLIDING SCALE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568331-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958833-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIGENTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568332-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568333-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934275-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BC PILL TRISPRINT TECH</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568334-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934553-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568335-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934547-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE DAYTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugindication>CARDIAC FAILURE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568336-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959251-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOUT CURE</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>WITH AFTERNOON MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120718</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568337-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934558-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>12 5MG EVERY OTHER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568338-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934461-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120508</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568339-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934959-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DEGENERATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MGX2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568340-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0963143-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q 10</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEGRETOL-XR</medicinalproduct>
        <drugdosagetext>600 DAILY</drugdosagetext>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>75MCG DAILY</drugdosagetext>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40 DAILY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568341-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935358-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>?MG EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568342-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934961-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568343-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934549-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568344-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934590-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568345-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891084-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PETECHIAE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugdosagetext>150 MG BID EVERY OTHER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>ALTERNATES WITH RANITIDINE ALTERNATES WITH RANITIDINE EACH OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLORINEF</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMANTADINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568346-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961773-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568347-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0956938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568348-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890651-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>12</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568349-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958349-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568350-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891294-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568351-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952838-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>134.38</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugdosagetext>40MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugdosagetext>160MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugdosagetext>40 MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120630</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568352-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957619-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568353-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891306-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>50</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHOKING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>PT NOT GOING TO TAKE ANY FURTHER DOSES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568354-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891302-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, 1 HOUR PRIOR TO BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C PLUS VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568355-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120716</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957443-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>13048AF</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BIO EQUAVALENT HORMONE REPLACEMENT</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>COMPOUNDED JUST FOR HER</drugdosagetext>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>HORMONE REPLACEMENT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>13048AF</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568356-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891307-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568357-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958386-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>021656</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568358-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891314-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568359-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932414-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG ONE WEEK</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568360-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932421-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER CAPSULES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568361-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891312-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568362-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120718</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0957583-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>BID ONE AT MORNING AND ONE AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568363-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891353-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568364-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120720</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958716-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568365-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891359-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME, DOSAGE INCREASED</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568366-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958313-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>CHEWABLE 30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568367-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932425-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568368-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932718-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568369-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0962115-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120724</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568370-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932801-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHADONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C AND E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568371-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961314-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568372-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891346-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568373-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932828-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568374-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932707-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>NASOPHARYNGITIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568375-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120719</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958328-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKING IT BEFORE GOING TO BED AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>40MG DAILY EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568376-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932410-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568377-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932722-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568378-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120505</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932715-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568379-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120705</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952828-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568380-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891467-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>CAROTID ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568381-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932710-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568382-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120721</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958746-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120718</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568383-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932422-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568384-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933233-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLITIS ISCHAEMIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIRISINT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50MG 1/2 TAB TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568385-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0958843-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568386-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933035-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CREATINE PHOSPHOKINASE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568387-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933383-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568388-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932762-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568389-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933222-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568390-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933759-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568391-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891432-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568392-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960742-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.064</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>DYSPEPSIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568393-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933440-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL FATTY ACIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH POTENCY</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIMATE FLORA</medicinalproduct>
        <drugdosagetext>50 BILLION LIVE CULTURE PER CAPSULE, ONE TABLET PER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 FATTY ACIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPA/DHA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568394-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932901-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FOR TWO WEEKS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568395-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932448-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATEVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL + D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568396-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961308-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568397-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934072-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568398-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933808-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568399-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932454-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG OXIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONDASTERON</medicinalproduct>
        <drugdosagetext>4MG TWICE A NEEDED</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugdosagetext>TWICE A DAY EACH NOSTRIL</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568400-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933766-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.6</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568401-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933347-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCHLORPERAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/12</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYUREA</medicinalproduct>
        <drugindication>BLOOD DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILODIPINE BESYLATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568402-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568403-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0959181-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCORRECT DRUG ADMINISTRATION DURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568404-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933814-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568405-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568406-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934132-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG, 30 MINUTES PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568407-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0960750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN INHALER</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTICS</medicinalproduct>
        <drugindication>GASTRIC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568408-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934156-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120508</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568409-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934070-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETRIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGIEN PATCH</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120509</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568410-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934124-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>5MG EVERY OTHER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETIC MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568411-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899488-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568412-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899306-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>OCCASIONAL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568413-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899019-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CARDIAC FLUTTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM W/VITAMIN D</medicinalproduct>
        <drugdosagetext>1200 + 1000 IU</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50MG-75MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKEN AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WOMEN'S MULTIVITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG INTOLERANCE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568414-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120506</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932770-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568415-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932852-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>WHILE ON SIMCOR + NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEASONAL RHINOCORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>1000/20MG (2 PILLS) AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568416-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933877-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568417-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901893-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.646</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>4 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>NECK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568418-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933760-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120503</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568419-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935754-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>145.28</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120512</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR XR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIMOVO</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568420-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952950-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568421-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934613-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568422-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892946-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568423-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934856-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568424-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120512</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934874-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568425-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935727-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120510</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>2 IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN LAXATIVE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>2 AT DINNERTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568426-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935357-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBEE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONOPICIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>1/2 OF 20/12.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568427-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120513</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934965-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.278</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568428-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935201-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568429-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935671-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TARCA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568430-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935308-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568431-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892960-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568432-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892944-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PEMEDICATES WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568433-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893022-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568434-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893759-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568435-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935710-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TESTICULAR PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568436-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893269-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIBIDO DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HANGOVER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568437-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA010319</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>STEVENS-JOHNSON SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULOMUCOCUTANEOUS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugauthorizationnumb>021995</drugauthorizationnumb>
        <drugdosagetext>50 MG, QD</drugdosagetext>
        <drugtreatmentduration>24</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568438-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-2012SP022371</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>CONTRACEPTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100514</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568439-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-009507513-1207USA012737</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DR. SCHOLL'S INGROWN TOENAIL PAIN RELIEVER</medicinalproduct>
        <drugbatchnumb>2YC</drugbatchnumb>
        <drugdosagetext>UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568440-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20100507</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>GB-009507513-2009SP022956</companynumb>
    <primarysource>
      <reportercountry>UNITED KINGDOM</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>METABOLIC SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>UNK UNK, UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SCHIZOAFFECTIVE DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VALPROATE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugdosagetext>15 MG, QAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METABOLIC SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugdosagetext>600 MG, QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>RISPERIDONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DULOXETINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugdosagetext>225 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>QUETIAPINE FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugauthorizationnumb>020415</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568441-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1106USA02726</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLAMMATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATROPHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRIST FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSTHYMIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BODY TEMPERATURE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC LESION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADJUSTMENT DISORDER WITH ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OXYGEN SATURATION DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEMUR FRACTURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC POLYPS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIATUS HERNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERSONALITY DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND INFECTION STAPHYLOCOCCAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATELECTASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIMB DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020310</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120219</drugenddate>
        <drugtreatmentduration>3634</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX PLUS D</medicinalproduct>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090119</drugenddate>
        <drugtreatmentduration>756</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
        <drugtreatmentduration>3650</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPOTHYROIDISM</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020108</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111214</drugenddate>
        <drugtreatmentduration>3628</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090105</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110730</drugenddate>
        <drugtreatmentduration>945</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19960101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugauthorizationnumb>020560</drugauthorizationnumb>
        <drugdosagetext>70 MG, QW</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20001211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050922</drugenddate>
        <drugtreatmentduration>1747</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>150 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050819</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20070211</drugenddate>
        <drugtreatmentduration>579</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568442-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893173-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>A LOT OF OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568443-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893529-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROSTATOMEGALY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110115</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALADIN TOPICAL CREAM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568444-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893182-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKING SAMPLE PACK 1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568445-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>IT-CELGENEUS-083-21880-12053031</companynumb>
    <primarysource>
      <reportercountry>ITALY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NON-HODGKIN'S LYMPHOMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>REVLIMID</medicinalproduct>
        <drugauthorizationnumb>021880</drugauthorizationnumb>
        <drugdosagetext>10 MILLIGRAM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LYMPHOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100121</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101123</drugenddate>
        <drugtreatmentduration>306</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568446-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG WITH DOSE OF NIAPSAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568447-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120524</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932442-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GLAUCOMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTRAOCULAR PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568448-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568449-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899899-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568450-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893509-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568451-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568452-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893369-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568453-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120507</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933240-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED OTC ALLERGY PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568454-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893177-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568455-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899883-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HIV MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568456-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933415-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568457-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893508-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568458-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900153-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568459-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935761-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOBILITY DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUROPATHY PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DRUG RESTATED</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568460-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899875-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568461-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902657-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>50.848</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANOLAZINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>CHEWABLE, PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568462-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900714-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568463-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902606-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568464-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934155-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568465-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901895-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME; ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG BID</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG AT BEDTIME; ONCE PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568466-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901957-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568467-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900621-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHROPATHY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568468-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933793-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568469-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903647-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568470-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0961629-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.33</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568471-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935689-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABLETS EVERY NIGHT AT 8:30</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568472-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935311-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.376</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER NOT REPORTED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568473-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934552-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY THROAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568474-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934596-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugdosagetext>MD IS AWARE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568475-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935722-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568476-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934964-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568477-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934598-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MS CONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MV</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG, AT BEDTIME WITH 325MG ASA</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568478-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120107</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890636-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568479-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935269-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568480-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890650-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.68</patientweight>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EPLERENONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568481-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.186</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120511</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568482-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891087-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG DAILY AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325 MG DAILY IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568483-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899416-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568484-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568485-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935335-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568486-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894117-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME; INTERRUPTED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120110</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568487-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891300-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568488-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935303-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568489-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899023-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>HALF OF A TABLET AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568490-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891319-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABOUT 20 UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568491-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935678-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568492-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935271-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.032</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568493-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891368-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUID PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568494-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893844-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568495-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891296-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111225</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111231</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN (GENERIC)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568496-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935694-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>TYPE IIA HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568497-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893171-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120106</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568498-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899403-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568499-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568500-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893170-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>128.03</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHALOEIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568501-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891465-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.462</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568502-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893764-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568503-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935670-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN-WOMEN A DAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMROSE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARITHROTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568504-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568505-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893655-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.014</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT 1800</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120113</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568506-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893181-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKEN TOGETHER WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568507-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935674-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568508-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932415-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568509-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893698-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568510-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY, IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMICTAL</medicinalproduct>
        <drugindication>CONVULSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568511-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-009507513-1207JPN012667</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TEMODAL</medicinalproduct>
        <drugauthorizationnumb>022277</drugauthorizationnumb>
        <drugdosagetext>DOSAGE UNKNOWN DURING A DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MALIGNANT GLIOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120701</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568512-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932411-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568513-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568514-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893567-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568515-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893178-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568516-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899578-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PTAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568517-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893533-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120102</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568518-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893328-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568519-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899939-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BETAPACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568520-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899300-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APPLE CIGER VINEGAR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POMEGRANATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568521-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899499-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.886</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UINKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120131</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568522-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899567-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ASTHENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568523-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899513-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568524-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902578-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HEREDITARY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568525-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901953-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE CHRONIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROTEIN TOTAL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568526-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0933386-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568527-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120114</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893184-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120103</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568528-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900814-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568529-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899991-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568530-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900618-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568531-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899615-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568532-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899979-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE PATCH DOT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPRION HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568533-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899972-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AXZOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568534-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902864-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY 30 MINUTES PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMROSE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTER C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568535-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892871-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OLIVE LEAVES EXTRACT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED GRAPE EXTRACT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568536-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892870-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568537-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895675-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568538-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894138-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568539-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898030-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568540-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897549-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>BLOOD IRON INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568541-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892872-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TEST ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3000 MG DAILY FOR 6 MONTHS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568542-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1TAB IN AM AND 2TAB AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2TAB IN AM AND 1TAB AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568543-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898033-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUMETANIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568544-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895666-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NADOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568545-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120730</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-EISAI INC-E2080-00522-SPO-US</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA ASPIRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SABRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFANTILE SPASMS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110902</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SABRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111019</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUCOVORIN CALCIUM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B6</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENOBARBITAL TAB</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KEPPRA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BANZEL</medicinalproduct>
        <drugauthorizationnumb>201367</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SABRIL</medicinalproduct>
        <drugdosagetext>1200 MG IN AM AND 1000 MG IN PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120625</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568546-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934847-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE - 30 MINUTES PRIOR TO BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568547-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899941-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568548-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934877-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568549-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902042-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30-45 MINUTES PRIOR TO DOSE NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568550-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902111-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568551-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934993-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>IRRITABILITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120506</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568552-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568553-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892059-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>163.44</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568554-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902614-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.842</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PERIPHERAL COLDNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESS LEGS SYNDROME</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568555-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936534-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG 30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>25MG 2 TIMES DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568556-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935286-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q 10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568557-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902045-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568558-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903708-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568559-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936677-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COELIAC DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568560-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMNARIS</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568561-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936280-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.376</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE TIGHTNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568562-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891823-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SUGAR PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120109</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568563-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902607-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.198</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568564-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891826-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568565-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.978</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568566-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902579-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FOR LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568567-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891744-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBEE</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568568-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935769-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN NORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568569-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936527-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568570-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936146-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ISCHAEMIC HEART DISEASE PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN DRUG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568571-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892076-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568572-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902006-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN PAIN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568573-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936423-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568574-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936558-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN GERD MEDICATION</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KAPIDEX</medicinalproduct>
        <drugdosagetext>EVERY MORNING AND EVERY AFTERNOON</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120518</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568575-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568576-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892077-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568577-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891822-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONOPIN</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEFLUNOMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANTAINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM OR FLEXERIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM OR FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BEXTRA</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>1 OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568578-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892321-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568579-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891825-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568580-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899413-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FULL LIST NOT REPORTED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568581-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120110</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891821-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568582-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894121-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENEFIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FROVA</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RYZOLT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIZANIDINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568583-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892070-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE PILLS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568584-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936559-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO BI-FLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568585-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892323-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>COMBINATION DRUG THAT CONTAINED NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568586-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892943-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>14 UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568587-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892317-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568588-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892083-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIVIERT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZERTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>PRIOR TO DINNER WITH 162 MG ASA</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DINNER WITH NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MYOCARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVASIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568589-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897228-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568590-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899365-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOVIAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POLYETHYLENE GLYCOL</medicinalproduct>
        <drugdosagetext>33/50</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568591-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892319-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568592-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897627-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568593-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892867-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568594-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892869-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568595-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120116</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893751-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568596-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892596-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>116.68</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENZOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568597-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897274-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.486</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568598-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892609-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568599-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120120</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895624-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568600-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899852-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19980101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568601-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892597-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120112</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568602-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897316-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.812</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG QPM</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111231</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG QPM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568603-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894246-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKES WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLCRYS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568604-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899738-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>SPORADICALLY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOMA</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>SLEEP DISORDER THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568605-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120112</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892592-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568606-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897331-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568607-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894271-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE MONONITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/25MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568608-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894278-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568609-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892794-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMOXICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568610-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0899989-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSAARTAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>CURRENT DOSE</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568611-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTENTIONAL DRUG MISUSE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111121</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568612-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897366-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568613-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898036-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.836</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA OR FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568614-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120205</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902448-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568615-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936077-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568616-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902007-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.702</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568617-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902108-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>ATHEROSCLEROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHLORTHALIP</medicinalproduct>
        <drugdosagetext>STATED THAT IT IS A WATER PILL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROPINOROLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568618-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936003-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568619-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901997-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugdosagetext>15/850MG TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568620-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902577-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THIRST</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568621-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935800-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.922</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568622-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934617-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568623-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OPTIMA 1100 BLOOD SUGAR SUPPORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PC95 GRAPESEED EXTRACT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568624-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0891913-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568625-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902489-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568626-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120511</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934881-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120311</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568627-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935997-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THROAT IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568628-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902492-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE OTC SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568629-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900795-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568630-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934997-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568631-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568632-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935329-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugdosagetext>DOSE NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS VITAMIN D</medicinalproduct>
        <drugdosagetext>DOSE NOT REPORTED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568633-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903689-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTISONE ACETATE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568634-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0893020-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIOXIDANT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568635-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935744-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568636-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936533-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2 PO IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500MG IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG PO IN MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568637-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892451-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568638-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935682-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568639-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936420-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 TAB AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568640-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936422-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA-D 12 HOUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT 8PM</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568641-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892327-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568642-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120113</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892799-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANSOPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568643-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898055-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568644-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900140-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568645-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915035-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE TAKING THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>2MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568646-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922523-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568647-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922461-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LAZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOZATAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568648-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916048-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VASOTEC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568649-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897267-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>NO INDICATION IF REQUIRED SINCE STARTING NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XOPENEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568650-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946259-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568651-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946006-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 PILL EVERY NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568652-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568653-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915357-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 3 AND 6</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVI FOR MEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568654-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897394-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG; IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568655-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0945966-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568656-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOMOTIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENTYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568657-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120405</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922597-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOUT MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568658-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922445-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSES OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN NON-PRESCRIPTION MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568659-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897378-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>MONDAY, WEDNESDAY, AND FRIDAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE NIASPAN</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568660-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923582-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKONWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568661-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0945841-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120516</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568662-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922621-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568663-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20030101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568664-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568665-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946160-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568666-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568667-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900179-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CRYSTAL URINE PRESENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMPONI</medicinalproduct>
        <drugdosagetext>AUTOINJECT SHOT</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568668-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922881-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568669-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568670-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898988-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DID NOT TAKE CONSISTENTLY</drugdosagetext>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568671-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914891-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>1000/20 AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568672-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120514</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935887-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARAFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKING IT EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120505</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120511</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568673-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898092-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG -EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568674-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568675-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121.22</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APPLE BASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACA ROOT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568676-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898969-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568677-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936029-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568678-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120509</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934185-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568679-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914957-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE TAKING NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568680-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914721-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568681-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914923-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568682-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914917-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.254</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568683-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898101-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568684-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120516</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936147-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.254</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568685-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914975-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568686-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934209-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120325</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568687-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898840-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568688-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914918-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2-500 MG AT BEDTIME</drugdosagetext>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568689-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936109-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC OTC MEDICATION</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568690-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914542-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>4X AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GERD MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5MG EVERY OTHER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568691-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915032-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568692-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914913-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>155.27</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUID RETENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120303</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>2 UNKNOWN BLOOD PRESSURE PILLS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WATER PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568693-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120517</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936415-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING JITTERY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>20-30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568694-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0945621-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>10 MINUTES AFTER DINNER, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568695-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120610</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946069-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOVEMENT DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFECTED BITES</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568696-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914921-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568697-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892067-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120106</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568698-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914529-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>139.38</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>K+</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568699-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900161-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568700-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946017-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM + VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568701-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914978-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED GOUT MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568702-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892325-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568703-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946256-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568704-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900206-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>NEUROPATHY PERIPHERAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE + ACETAMINOPHEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568705-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892063-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>139.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPRION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIAZPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>INTERRUPTED</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120111</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568706-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0945630-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.33</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568707-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900163-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568708-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120129</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568709-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914538-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568710-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892285-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568711-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915334-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568712-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934216-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugdosagetext>50/1000</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568713-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916054-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugdosagetext>500MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>180MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>40MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568714-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120111</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0892343-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHEMO THERAPY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568715-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0945835-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TERMINAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SUPPLEMENTS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugdosagetext>PRIOR TO HIS DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568716-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900303-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568717-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914552-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568718-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568719-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894125-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568720-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>60</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000MG DAILY DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568721-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914909-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING WITH NIASPAN DOSE 2-500 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568722-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IPRATROPIUM BROMIDE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568723-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894133-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568724-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946176-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMRON</medicinalproduct>
        <drugindication>NERVOUSNESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568725-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915977-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.426</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM PICOLINATE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>INTERVERTEBRAL DISCITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568726-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894262-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPOPROTEIN (A) ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568727-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914915-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD THINNER THERAPY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568728-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916053-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>52</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568729-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916062-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568730-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMERON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568731-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0894129-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568732-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568733-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915350-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568734-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916064-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568735-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946243-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>160MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG EVERY MORNING</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>325MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMROSE</medicinalproduct>
        <drugdosagetext>1300MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>100MCG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568736-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897244-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.794</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568737-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914912-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BP PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568738-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922489-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED APPETITE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECLINED LIST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568739-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922429-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568740-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900378-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568741-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897254-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568742-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568743-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898028-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568744-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898828-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROSTATIC SPECIFIC ANTIGEN INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN HCT</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568745-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898851-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568746-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568747-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902186-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>THROMBOSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568748-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0897315-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568749-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120510</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0934215-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA RED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN 50+ VITAMIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUSPIRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568750-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914719-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568751-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902438-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568752-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898031-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120124</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERBINAFINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568753-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898042-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568754-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER NOT REPORTED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568755-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914548-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HCTZ</medicinalproduct>
        <drugdosagetext>10/12.5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FELODIPINE</medicinalproduct>
        <drugdosagetext>5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568756-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120515</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0935900-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568757-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120128</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898843-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568758-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922780-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568759-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900482-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568760-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120713</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, BETWEEN 9 TO 9:30 AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>25/100 MG TAKING HALF TABLET</drugdosagetext>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568761-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922439-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568762-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915421-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.486</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568763-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903022-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOTRIGINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568764-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900168-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugindication>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568765-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900158-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSE OF OPPRESSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MILK THISTLE</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLCHOL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>HEART VALVE REPLACEMENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTOFF</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568766-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922493-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568767-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903485-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MORPHINE SULFATE</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568768-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923110-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.996</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM PLUS VIT D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568769-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950892-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568770-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915954-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568771-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903068-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568772-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926335-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568773-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950736-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568774-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916249-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568775-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923588-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568776-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950257-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME, FOR UNSPECIFIED AMOUNT OF TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>? MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>? MG EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>EVERY DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568777-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951543-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568778-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORMADYNE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568779-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924839-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOCLASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>60MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>OFF AND ON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME THEN SLOWLY INCREASED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568780-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903065-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568781-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568782-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904665-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>HYPERLIPIDAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568783-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903366-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120110</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568784-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922894-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568785-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903421-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT AFTER SUPPER</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568786-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903371-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568787-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923255-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568788-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925745-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568789-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120313</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914906-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>200MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568790-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915505-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 PILLS FOR 2 YEARS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568791-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922627-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568792-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923591-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568793-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898037-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568794-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923284-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568795-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120131</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900493-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568796-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914335-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120308</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568797-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898972-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS IN AM AND 2 TABS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568798-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923270-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG 1/2 TAB QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568799-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900410-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568800-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951233-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINEMET</medicinalproduct>
        <drugdosagetext>25/125 MILLIGRAMS, 3 IN 1 DAYS</drugdosagetext>
        <drugindication>PARKINSON'S DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DONPEZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugdosagetext>150MG DAILY</drugdosagetext>
        <drugindication>NARCOLEPSY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HEART RATE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568801-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900484-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568802-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923599-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT AROUND 9-9:30PM</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110925</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>HALF HOUR BEFORE TAKING NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568803-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950872-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CHOLESTEROL LOWERING MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568804-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950377-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>LOW DOSE BEFORE NIASPAN</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568805-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915577-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>THOUGHT DOSE WAS 500 MG, BUT NOT CERTAIN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120309</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120312</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568806-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0945626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568807-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915581-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568808-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923154-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>119.86</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568809-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946016-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568810-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951537-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568811-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950439-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AFTER LUNCH</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120626</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568812-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0945963-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GREEN TEA EXTRACT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568813-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950744-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 X 2 TABLETS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568814-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950916-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE THE NIASPAN AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568815-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922399-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568816-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568817-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946157-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>GLUCOSE TOLERANCE IMPAIRED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568818-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903332-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568819-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950438-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568820-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924827-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG, AT 07:30PM</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568821-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922591-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568822-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950224-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568823-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903425-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568824-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950379-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.486</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>YELLOW SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568825-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922602-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568826-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950887-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ARTHRITIS</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugdosagetext>AS REQUIRED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568827-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925230-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZITHROMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120404</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568828-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903260-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568829-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925756-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC DIATHESIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568830-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950816-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568831-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915918-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER LIQUID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568832-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925924-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES AROUND 9PM TO MIDNIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568833-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0949842-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SECRETION DISCHARGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>ALTERNATES BETWEEN 2.5 AND 5MG ONCE QDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugdosagetext>300 MG PER DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIFLEX</medicinalproduct>
        <drugdosagetext>TWO TABLETS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200MG FIVE TABS PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugdosagetext>300 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>145 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE HCL</medicinalproduct>
        <drugdosagetext>150 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>50 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ-10</medicinalproduct>
        <drugdosagetext>100 MG PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568834-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950414-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568835-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915572-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.462</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE AND ACETAMINOPHEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGESTROL ACETATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>VASCULAR OCCLUSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120312</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568836-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924818-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SNEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RHINORRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG EITHER 1/2 TAB OR 1 FULL TAB ALTERNATING</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568837-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugdosagetext>INFUSION</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120309</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568838-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923228-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CORTICOSTEROIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568839-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916063-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG ER TAKING AT 10PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568840-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120210</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903389-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FRUSTRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHOLELITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STAPHYLOCOCCAL INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WOUND</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568841-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950800-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120622</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILIZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568842-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120312</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916059-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYBUTYNIN</medicinalproduct>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568843-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916262-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CHONDRIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568844-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903456-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568845-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903028-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568846-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922314-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG IN AM, 25 MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568847-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALDACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELETONIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHENIRAMINE MELEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRASTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIGLIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCORTISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568848-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925245-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.946</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG, EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120329</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugdosagetext>10 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>37.5/25 MG DAILY</drugdosagetext>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>0.1 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568849-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903238-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568850-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904664-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568851-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903258-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSKINESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNKOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568852-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925399-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568853-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903248-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BRONCHITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AUGMENTIN '500'</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568854-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904641-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568855-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926138-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ROSACEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568856-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MACULAR OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111102</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120110</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568857-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120207</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903469-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN/HYDROCHLOORTHIAZIDE</medicinalproduct>
        <drugdosagetext>100/12.5 MILLIGRAMS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568858-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923038-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120402</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568859-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904690-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568860-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925904-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CIALIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568861-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926350-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568862-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926296-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUMATRIPTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAM-E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKEN 30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568863-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903069-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASA COATED</medicinalproduct>
        <drugdosagetext>325 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>50 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND</medicinalproduct>
        <drugdosagetext>8 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568864-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923539-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.934</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECLINED LIST</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568865-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120130</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900166-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>ANGIOPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMULIN 70/30</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568866-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922466-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugdosagetext>EVERY TWO WEEKS</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568867-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120408</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922631-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugdosagetext>OTC</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120208</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568868-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923401-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568869-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120407</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922637-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 PO AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568870-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923940-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568871-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923559-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20041201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568872-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915920-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CATARACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FURASEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYLOPRIM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568873-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922891-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568874-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950246-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568875-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915297-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568876-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950230-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAVATAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568877-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0914984-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568878-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915855-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568879-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0922944-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>25 MG 1/2 DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568880-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0902989-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ONE HOUR PRIOR DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568881-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0915309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568882-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugdosagetext>15MG/500MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2-750 MG DOSE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568883-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923443-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568884-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903018-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568885-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950251-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568886-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950422-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES DOSE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568887-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904228-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANOTHER CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568888-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916260-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN VEGETABLE SUPPLEMENT</medicinalproduct>
        <drugindication>CONSTIPATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120303</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568889-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925215-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568890-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905116-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE AND METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>500/5, 2 IN1 D</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568891-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927598-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568892-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925321-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568893-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120421</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928137-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568894-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927738-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.51</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LDL/HDL RATIO INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20000101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20060101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NICARDIPINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>30 UNKNOWN SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568895-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905044-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568896-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926730-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LOW DENSITY LIPOPROTEIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugindication>AGE-RELATED MACULAR DEGENERATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568897-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927779-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120413</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568898-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927754-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568899-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOPTIC</medicinalproduct>
        <drugdosagetext>RIGHT EYE</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568900-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926796-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>114.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MIN PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG 2 PO QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568901-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905043-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN CR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STADOL</medicinalproduct>
        <drugdosagetext>SPRAY</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugdosagetext>SPRAY</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120210</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIBENZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120212</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568902-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928262-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568903-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925352-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568904-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927729-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPO-PROVERA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568905-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926789-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTA C</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568906-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928175-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION ERROR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568907-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905034-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568908-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-011158</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBAVIRIN</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120513</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120513</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568909-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926136-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568910-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927691-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ARTHRITIS MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568911-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927104-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROSTAT</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ROXICET</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568912-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>LOWER DOSES</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120215</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568913-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928142-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN DOSE, DAILY AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MIN PRIOR TO TAKING NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568914-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926093-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOTRIN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568915-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923945-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ENERGY INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG 30 MIN. PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568916-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926729-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568917-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904164-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMAPRIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568918-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925347-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568919-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926303-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568920-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950225-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568921-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926717-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENIOR VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100404</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568922-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925319-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ARTERIAL DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CADUET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568923-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950229-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568924-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120109</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890501-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO HIS DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568925-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120415</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926998-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568926-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120309</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916218-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ERGO D SOFTGEL CAPSULE</medicinalproduct>
        <drugdosagetext>MONDAY AND THURSDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugdosagetext>2 SPRAYS EACH NOSTRIL ONCE A DAY</drugdosagetext>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugdosagetext>1 ON MONDAY, WEDNESDAY AND FRIDAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSTENSIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>EVERY AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICRO-K</medicinalproduct>
        <drugdosagetext>1 ON MONDAY, WEDNESDAY AND FRIDAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERDIUM VEGETABLE LAXATIVE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TMG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEL BASED STOOL SOFTENER</medicinalproduct>
        <drugadministrationroute>054</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVASIN</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RECLAST</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITIZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENERGAN HCL</medicinalproduct>
        <drugdosagetext>1/2 TO 1 TABLET EVERY 6 HOURS AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT HOUR OF SLEEP</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022224</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568927-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925372-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568928-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120625</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0949988-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568929-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890503-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEOBIFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568930-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927302-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568931-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904280-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MALTAQ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LESCOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOTROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 IN AM 500 AT LUNCH 500 IN PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568932-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904158-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY COUPLE OF DAYS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568933-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120626</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950088-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPHAGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OROPHARYNGEAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MERCAPTOPURINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120620</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120625</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568934-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927107-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>115.77</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568935-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925864-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIVINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568936-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG 2 TABS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568937-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927747-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568938-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916065-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>HIGHER DOSE</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>LOW DOSE FOR 4 WEEKS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568939-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYOPATHY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568940-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925761-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.156</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120408</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETIC MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>5 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568941-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904309-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>CONSTIPATION PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20-25 MG, 1 IN 1 D</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568942-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927679-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568943-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903012-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>53.572</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120125</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHILDRENS GUMMIE MULTIVITAMINS</medicinalproduct>
        <drugdosagetext>TWO</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568944-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926341-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A)</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXYCYCLINE HCL</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANOTHER UNKNOWN PROSTATE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568945-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927624-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED SUGAR PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BLOOD PRESSURE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568946-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120628</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950809-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568947-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904310-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>131.66</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSGRAPHIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVE COMPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568948-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904704-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.174</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>THREE, AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ABILIFY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568949-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HAZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (CENTRUM SILVER) WITH NIACIN 20MG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COENZYME Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568950-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120627</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0950834-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568951-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904292-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568952-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904249-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX PR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY SHOT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTEPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568953-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904687-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MEDICATOIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568954-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120208</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903036-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568955-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568956-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916227-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568957-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927773-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568958-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120206</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903511-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568959-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904269-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.376</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AFTER LUNCH</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568960-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904349-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500MG, 1 IN 1 D, AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568961-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568962-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926461-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.486</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568963-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904533-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT WITH D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568964-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928416-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568965-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904662-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568966-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925269-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120409</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568967-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPIGASTRIC DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD THINNER MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568968-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904345-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN (COATED)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568969-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904685-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568970-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904718-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugdosagetext>OTC</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568971-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926733-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME (DOSAGE INCREASED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 AT BEDTIME FOR A SHORT TIME (DOSAGE INCREASED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME FOR ABOUT 2-3 MONTHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME (DOSAGE DECREASED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568972-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924833-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568973-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904618-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>121.67</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG QHS</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAKOTE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568974-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904734-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>45 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BP PILL (NAME NOT REPORTED)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ANTIBIOTIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568975-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926712-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG TAKING IT AT 10-11PM</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568976-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927255-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568977-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926703-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INITIAL INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETES MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568978-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925252-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BED TIME, DEPEND SEVERERITY FLUSHING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568979-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904803-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20071101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20080301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>ANTICOAGULANT THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070801</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20071101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HEART RATE DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568980-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926799-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG (2 TABS)</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568981-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927633-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568982-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925317-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKING IT AROUND 8 PM</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568983-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926757-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO DOSE OF NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG 2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568984-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHEH2012US015150</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>NEOPLASM MALIGNANT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZARIL</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugauthorizationnumb>019758</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568985-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120802</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>PHHY2012CA050028</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TRAUMATIC LUNG INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RIB FRACTURE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>20 MG, ONCE IN A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SANDOSTATIN LAR</medicinalproduct>
        <drugauthorizationnumb>021008</drugauthorizationnumb>
        <drugdosagetext>10 MG, ONCE IN A MONTH</drugdosagetext>
        <drugadministrationroute>030</drugadministrationroute>
        <drugindication>ANGIODYSPLASIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568986-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110921</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856615-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.41</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>20/12.5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DURING THE DAY</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110917</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DURING THE DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568987-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20111209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0882165-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN A</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>FROM SAMPLE PACK</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111209</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111209</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568988-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923361-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FATTY ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ARTERITIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568989-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926698-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>Q HS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568990-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926134-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120401</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568991-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924884-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568992-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925876-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>STARTED TAKING AT NOON, NOW TAKES AT HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568993-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120409</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923292-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568994-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926351-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTENONOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568995-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926222-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugdosagetext>500MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200MG 4 TABS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugdosagetext>2 TABS DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120220</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568996-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925247-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568997-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925878-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT 10PM EACH NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>45 MIN PRIOR TO NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568998-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120406</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923645-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATELVIA</medicinalproduct>
        <drugindication>OSTEOPENIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>DIZZINESS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8568999-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926686-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>TWICE WEEKLY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569000-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120416</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926308-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HEART MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SINUS MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569001-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120413</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0925344-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RESTLESSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LIPID METABOLISM DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569002-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890500-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569003-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905660-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDS NOT REPORTED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569004-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927751-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569005-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906098-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569006-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905734-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RHTHMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569007-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916236-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569008-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905665-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPLUS MET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXYZ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569009-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905464-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569010-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904319-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569011-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906061-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIPIDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>11:00 AM WITH LUNCH</drugdosagetext>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569012-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929550-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLORATABS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120417</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120424</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHOLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTENONOL</medicinalproduct>
        <drugdosagetext>75 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569013-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904731-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569014-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929056-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>136.2</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GOUT MED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569015-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904669-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569016-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905652-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569017-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906053-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPOPROTEIN (A) ABNORMAL</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME (1000 MG + 500 MG TABS)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569018-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928744-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANEXA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugdosagetext>SLIDING SCALE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER EVENING MEAL, AT 7PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569019-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928757-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHOLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>UNKNOWN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569020-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929389-00</companynumb>
    <primarysource>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZONEGRAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569021-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929310-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569022-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929544-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110901</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569023-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927308-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569024-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928788-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569025-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916824-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NIGHT SWEATS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569026-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929105-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARRHYTHMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugdosagetext>80MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugdosagetext>2.5MG TEN TABLETS A WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.25MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugdosagetext>1MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>ONE TAB TWICE A WEEK PRIOR AND AFTER METHOTREXATE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569027-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929589-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569028-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927597-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.996</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE MSM</medicinalproduct>
        <drugdosagetext>1500 TAB</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>100</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>100</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>1200M</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569029-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929555-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MASS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY INJECTION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASTELIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569030-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917096-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120314</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569031-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916652-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTANESE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>APOLIPOPROTEIN A-I ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569032-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927193-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569033-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929046-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569034-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916450-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569035-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916841-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OSTEOPOROSIS MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569036-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916727-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569037-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916788-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569038-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927767-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES 1 AT 9PM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120415</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED DOSE</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569039-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929022-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZEDONE</medicinalproduct>
        <drugdosagetext>50MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORTRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569040-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946698-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SANCTURA</medicinalproduct>
        <drugindication>HYPERTONIC BLADDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120612</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569041-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916819-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>HALF DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569042-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-010368</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.405</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ALOPECIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANORECTAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PROCTALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OPTIC NERVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCRIT</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANAPROX DS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugbatchnumb>263042</drugbatchnumb>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATIVAN</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENJUVIA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CODEINE</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120531</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120724</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUMETZA ER</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIPHEX EC</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569043-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916799-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.168</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WEIGHT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569044-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120317</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916294-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POSTMENOPAUSAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569045-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905189-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569046-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904865-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569047-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904227-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569048-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905183-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569049-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120314</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916095-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.278</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120313</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022224</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569050-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904864-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569051-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928070-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>59</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>101542E</drugbatchnumb>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIFERA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>MINERAL SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUDESONIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESICARE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENTASA</medicinalproduct>
        <drugdosagetext>500MG 2 CAPSULES 4 TIMES DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORD/CLIDI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569052-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929017-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>103.97</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN CREAM</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PSORIASIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120325</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569053-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928140-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569054-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906057-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>TWO 1000MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEUTIN EYE DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TWO 81MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569055-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929119-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569056-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904279-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569057-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928171-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TONGUE DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWOLLEN TONGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569058-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906094-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569059-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929322-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANGINA PECTORIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZALATAN</medicinalproduct>
        <drugindication>OCULAR HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569060-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928591-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INFLUENZA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN HYPERTENSION MEDICATION</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIABETES MEDICATION</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ARTHRITIS MEDICATION</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569061-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928684-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569062-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904471-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569063-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929121-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569064-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>SI-FRI-1000037557</companynumb>
    <primarysource>
      <reportercountry>DENMARK</reportercountry>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>65</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PSYCHOMOTOR HYPERACTIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY INCONTINENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DELIRIUM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>DEPRESSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569065-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928638-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DANDRUFF</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120409</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569066-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928695-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569067-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928740-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569068-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904358-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569069-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-FRI-1000037530</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SUICIDAL IDEATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEPRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AFFECTIVE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugauthorizationnumb>020822</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ROFLUMILAST</medicinalproduct>
        <drugauthorizationnumb>22522</drugauthorizationnumb>
        <drugdosagetext>500 MCG</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120116</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120310</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569070-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904755-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG IN THE MORNING</drugdosagetext>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120210</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569071-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928688-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>WITH 20MG NIACIN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120416</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BABY OR LOW DOSE OF ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569072-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904610-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>IN THE AM, WITH 2 BABY ASPIRIN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFLAVONOID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE AM, WITH LEVOTHYROXINE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRATEST H.S.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>0.50, TWICE A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICODIN ES</medicinalproduct>
        <drugdosagetext>2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUSH FREE NIACIN</medicinalproduct>
        <drugdosagetext>2 IN THE AM AND PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569073-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929587-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMINS (WOMAN A DAY)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569074-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905045-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED OEDEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FACE OEDEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVANDIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569075-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929530-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGESTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DOSE AT BEDTIME AS DIRECTED BY MD</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569076-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLIN N</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REQUIP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVULIN REGULAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>LOW DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TORSAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL WITH EXTRA D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569077-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0904797-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569078-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdisabling>1</seriousnessdisabling>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-009507513-1208USA000205</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>4</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>PULMONARY EMBOLISM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NUVARING</medicinalproduct>
        <drugauthorizationnumb>21187</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090801</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569079-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928702-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugdosagetext>70/30</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN (NAME NOT SPECIFIED)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569080-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929603-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIO TEA</medicinalproduct>
        <drugdosagetext>GREEN TEA SUPPLEMENT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>20/12.5MG EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugdosagetext>10MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIO MVI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INVESTIGATION ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569081-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929045-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569082-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906059-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569083-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.922</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN WATER PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120411</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569084-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928739-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.85</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIABETES MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569085-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926360-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>Q DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>REPLACED LIPITOR</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569086-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928975-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>62</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569087-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929318-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569088-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929014-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569089-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926713-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASOCAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT 5AM AND 7PM</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569090-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929760-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569091-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929537-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30-60 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569092-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929015-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569093-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926716-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH THE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3-500MG TABLETS AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569094-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929031-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG OR 325MG WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>4 EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569095-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928927-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569096-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926808-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PHENTERMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120413</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>5</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569097-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928805-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.7</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTORIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569098-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928730-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120421</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569099-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926999-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120328</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120403</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120404</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569100-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929039-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569101-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120424</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929020-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BISOPROLOL FUMARATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569102-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929739-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569103-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917187-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569104-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916414-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>2</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>2 IN AM 1 AT BEDTIME</drugdosagetext>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN SR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTIN HCTZ</medicinalproduct>
        <drugdosagetext>100/25</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITEN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569105-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927676-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TOOK DOSE LAST NIGHT BEFORE BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120418</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OTHER MEDICATION(S)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569106-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>CA-ACTELION-A-US2012-69347</companynumb>
    <primarysource>
      <reportercountry>CANADA</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>61</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TRACLEER</medicinalproduct>
        <drugauthorizationnumb>021290</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569107-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-ACTELION-A-US2012-68013</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>46</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PLEURISY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VENTAVIS</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120522</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569108-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856906-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELATONIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40 MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FIBER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569109-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>NL-ROCHE-1091808</companynumb>
    <primarysource>
      <reportercountry>NETHERLANDS</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientweight>71.5</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CARDIAC FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL FAILURE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>METASTATIC MALIGNANT MELANOMA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110912</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120624</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VEMURAFENIB</medicinalproduct>
        <drugauthorizationnumb>202429</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120712</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569110-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20110922</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-11P-163-0856914-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569111-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0926126-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>63</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>OFF LABEL USE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HALLUCINATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MIGRAINE MED</medicinalproduct>
        <drugindication>MIGRAINE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569112-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120418</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927997-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120412</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569113-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927341-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCULOSKELETAL PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 HOUR PRIOR TO NIASPAN (COATED)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569114-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905046-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569115-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905473-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AFTER DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>1 IN 1 D, BEFORE DINNER</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIPLE UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569116-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120108</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0890486-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569117-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120417</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928557-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugdosagetext>5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL XR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>102122E</drugbatchnumb>
        <drugindication>RHEUMATOID ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORFLEX</medicinalproduct>
        <drugdosagetext>60MG/2ML AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEMAZEPAM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CVS FISH OIL</medicinalproduct>
        <drugdosagetext>SOFTGEL</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>102122E</drugbatchnumb>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>CROHN'S DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRONATURAL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN SODIUM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PUB RANITIDINE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569118-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927602-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569119-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905118-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120208</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569120-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905600-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>124.4</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PILOERECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>LOW DOSE IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENBREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBEE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENLERENONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVEDIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569121-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugdosagetext>40MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>200-25</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569122-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120420</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0927629-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569123-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929572-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>20-30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569124-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946483-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569125-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901012-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569126-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947344-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRADGENTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569127-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901011-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569128-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947065-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120613</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569129-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569130-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929726-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>A FEW WEEKS AGO</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569131-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946515-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569132-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941040-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>? MG AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME, 500 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569133-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900980-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ATHEROSCLEROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120130</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569134-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929093-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NISOLDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569135-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917629-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569136-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940879-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569137-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120425</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929026-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569138-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917652-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569139-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120710</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917269-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120315</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569140-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941033-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120524</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569141-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916747-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>12.5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569142-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901404-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569143-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917940-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>80.358</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569144-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901133-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMYTRIPTYLINE</medicinalproduct>
        <drugindication>HEADACHE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569145-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940894-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569146-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916809-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B-6/B-12 COMPLEX</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIURETIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569147-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940538-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>X 2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569148-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895792-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKES WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569149-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917214-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.41</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569150-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941090-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569151-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916792-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.922</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORALINA</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASIPHEX</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANZIDE</medicinalproduct>
        <drugdosagetext>20/12.5MG, 1/2 TABLET EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VESLCARE</medicinalproduct>
        <drugdosagetext>GIVEN 27 TABLETS AND TAKEN FOR 3 DAYS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120317</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569152-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120122</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896236-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KETOPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPECIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG - 30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111122</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM MVI</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569153-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917626-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKING IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569154-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947060-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME.PATIENT TOOK TOTAL OF 2 DOSES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569155-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895890-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.462</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>ARTHRALGIA</drugindication>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569156-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896524-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBIRIDE/METFORMIN</medicinalproduct>
        <drugdosagetext>2.5/500</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569157-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940563-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLEEDING TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569158-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900972-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXTRASYSTOLES</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569159-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120119</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895963-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569160-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917209-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>200 MG DAILY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569161-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940691-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569162-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908986-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLANK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN PAIN MEDICATION</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569163-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917544-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER FUNCTION TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME/DOSE DECREASED</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569164-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940514-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>20/12.5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>PO Q HS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRURITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569165-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120316</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917726-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120307</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XYZAL</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN RESTLESS LEG MEDICINE</medicinalproduct>
        <drugindication>RESTLESS LEGS SYNDROME</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569166-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941044-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSCAL 500-D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>SAMPLES 1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>10/650MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569167-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908974-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.714</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120221</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWO UNKNOWN HIGH BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWO UNKNOWN DIABETES MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NERVE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569168-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896130-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT ( TITRATED BACK UP)</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TITRATED TO 1000MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugdosagetext>NASAL SPRAY INHALER</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569169-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917173-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569170-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940943-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569171-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908945-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569172-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941025-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569173-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946489-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569174-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940547-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569175-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN C AND E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569176-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896226-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569177-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120613</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946558-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugdosagetext>1000</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAMOSIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUERCETINE</medicinalproduct>
        <drugdosagetext>2 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569178-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917658-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>87.622</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDOCIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPRAZOLAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN PAIN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569179-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909471-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569180-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896707-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569181-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917063-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRASTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NATURAL HERB BULGARIAN</medicinalproduct>
        <drugindication>ANDROGEN DEFICIENCY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569182-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916845-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>143.92</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569183-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928331-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569184-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120315</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916452-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569185-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917067-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500MG EVERY NIGHT</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120319</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALSASA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA RED 3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569186-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946755-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.198</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>POSTOPERATIVE CARE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMPRO</medicinalproduct>
        <drugdosagetext>1/2 TABLET A DAY</drugdosagetext>
        <drugindication>MENOPAUSAL SYMPTOMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569187-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916784-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>128.94</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL LA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>EVERY WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569188-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120419</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928583-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROBIOTIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569189-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916790-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.646</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COD LIVER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569190-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947055-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569191-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946274-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569192-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905170-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>12 HOURS ON AND 12 HOURS OFF</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569193-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946859-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569194-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059069</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PULMONARY FIBROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080305</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569195-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916766-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN WATER PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>4 UNKNOWN HIGH BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569196-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901028-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>TINEA PEDIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NIGHT WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugdosagetext>TAKEN WITH 50 MG NIACIN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569197-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946581-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONDITION AGGRAVATED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569198-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120216</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905157-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.652</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTRIC DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569199-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946866-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VINOVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569200-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916761-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugdosagetext>75MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>80MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugdosagetext>5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569201-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917540-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.186</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>JOINT SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ONYCHOMYCOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENDONITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAIL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CAROTID ARTERY OCCLUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN EXFOLIATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METROGEL</medicinalproduct>
        <drugdosagetext>TO FOREHEAD</drugdosagetext>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugadministrationroute>061</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569202-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946542-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569203-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905298-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASACOL</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE ANDROGEL 1 %</medicinalproduct>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugindication>PROSTATIC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569204-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAMIPEXOLE DIHYCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE FUROATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>APRISO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569205-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120614</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946265-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569206-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947071-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MENISCUS LESION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG 2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569207-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905738-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569208-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947129-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BOWEL MOVEMENT IRREGULARITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120617</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569209-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120215</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0905161-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569210-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120617</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946851-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT HS</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120609</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569211-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120201</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900998-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>EOSINOPHIL COUNT INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>250/50 ONE INHALATION 2 TIMES A DAY-RINSE MOUTH AFTER USING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>LUNG DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugdosagetext>HFA 2 INHALATIONS EVERY 6 HRS AS NEEDED</drugdosagetext>
        <drugindication>DYSPNOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROAIR HFA</medicinalproduct>
        <drugindication>WHEEZING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugdosagetext>1/2 PILL UP TO 2 TIMES A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569212-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947072-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569213-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120423</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0928646-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HEREDITARY DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569214-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946464-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>SOMETIMES AT BEDTIME AND SOMETIMES DURING DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN NASAL ALLERGY SPRAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>SOMETIMES AT BEDTIME AND SOMETIMES DURING DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120514</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MIN PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALAVERT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569215-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900984-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569216-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947122-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZ</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569217-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947281-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DERMATITIS CONTACT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120515</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569218-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929568-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JUNAMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY MEDICATION</medicinalproduct>
        <drugindication>SEASONAL ALLERGY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569219-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940558-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PAPULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569220-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901061-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.744</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GINGIVAL BLEEDING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRALAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROSCAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAZXONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE EXTRACT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYTOMEL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESYREL</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B1 TAB</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569221-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901035-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569222-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929578-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 TABS</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS OF ONE WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE TAB FOR ONE WEEK</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugdosagetext>EVERY 10 DAYS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALKA SELTZER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569223-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917538-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NASAL CONGESTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569224-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901147-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569225-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901242-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <reaction>
        <reactionmeddrapt>GLOSSODYNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ORAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIP PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>STOMATITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111001</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569226-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569227-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120319</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0916786-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugdosagetext>GERNERIC NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569228-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120320</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917182-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569229-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896364-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569230-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941042-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.67</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VISUAL IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DECREASED APPETITE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120524</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VALIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME X 7DAYS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120523</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>1/2 TABLET AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>SLEEP DISORDER</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569231-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946841-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE ABNORMAL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569232-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946495-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.886</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG DAILY AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM GLUCONATE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569233-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896371-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD BILIRUBIN INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>500/20 MG AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569234-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895848-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569235-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909334-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>48.124</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EMT/DS</medicinalproduct>
        <drugdosagetext>2.5/1.25</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569236-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909670-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OCULAR HYPERAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569237-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941032-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569238-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896711-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRIMIDONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569239-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901073-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRASTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569240-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896794-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569241-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120219</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909266-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>51</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugdosagetext>FOR MEN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>2 IN AM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RANITIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ORPHENADRINE CITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMIRA</medicinalproduct>
        <drugbatchnumb>120022E</drugbatchnumb>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120207</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugdosagetext>7.5/325 MG</drugdosagetext>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOBETASOL PROPIONATE</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569242-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120121</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896803-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569243-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910395-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569244-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909005-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.904</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1 IN 1 DAY AT 9 PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugdosagetext>1 IN 1 DAY AT 6 PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY AT 4 AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>1 IN 1 DAY AT 6 PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPAFENONE HCL</medicinalproduct>
        <drugdosagetext>1 IN 12 HOURS (AT 6 AM AND 6 PM)</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569245-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896861-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VENLAFAXINE</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TERAZOSIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569246-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONGLYZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569247-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909059-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569248-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909358-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.524</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569249-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG DOSE OMISSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ELAVIL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120321</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569250-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120321</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917640-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>TWO DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>1000/40MG AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569251-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941806-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TREATMENT NONCOMPLIANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569252-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910022-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>152.09</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAMIR</medicinalproduct>
        <drugdosagetext>EVERY EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569253-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910017-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>TAKEN BEFORE NIASPAN COATED DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569254-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943082-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569255-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910373-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569256-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940542-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569257-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909748-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120227</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569258-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910402-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120229</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120302</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NARCO</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569259-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942999-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTONEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MGX2 TABS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569260-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941529-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.702</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120529</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTRACET</medicinalproduct>
        <drugdosagetext>6 PILLS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569261-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895747-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120123</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569262-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910028-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.302</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIVELLE-DOT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569263-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941109-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569264-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942905-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>14 UNKNOWN DIFFERENT PILLS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENSIPAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569265-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940936-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569266-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942043-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>EVERYDAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q-10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569267-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910374-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>122.58</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTARA (MICRONIZED)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVACHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TEKTURNA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569268-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942893-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION X 2.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569269-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910045-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL STIFFNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120226</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120229</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569270-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895871-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569271-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910047-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120224</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569272-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942316-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569273-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898105-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.524</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INCREASED TENDENCY TO BRUISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +VIT D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACIDOPHYLLUS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D3</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569274-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941105-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569275-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895865-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569276-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569277-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910199-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugdosagetext>30-30-35 AT MEALS THREE TIMES DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugdosagetext>1 IN 1 D, AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569278-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943041-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>X2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGARED 300</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>HALF TABLET</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXCARBAZEPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569279-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910196-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VARIOUS STATINS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569280-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugdosagetext>AT HS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHRIPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROGRAS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569281-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941321-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120523</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTIM</medicinalproduct>
        <drugindication>BLOOD TESTOSTERONE DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569282-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910218-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569283-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943540-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHITE BLOOD CELL COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NEUTROPENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569284-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910192-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ALCOHOL</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>20381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN COATED DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569285-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896504-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569286-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941807-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.726</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090509</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASACORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETAMINOPHEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DITIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PULMICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569287-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898121-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.93</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWO UNKNOWN BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569288-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569289-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896661-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30-1 HOUR PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120103</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569290-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569291-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943512-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569292-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943395-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569293-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910041-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569294-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908934-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HELICOBACTER INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 PILLS; THINKS WAS 2000 MG</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569295-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942857-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569296-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943413-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569297-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930011-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HERPES ZOSTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120407</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569298-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD URIC ACID INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569299-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909327-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOIWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOIWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569300-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942786-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PROTHROMBIN TIME PROLONGED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THERAPEUTIC RESPONSE UNEXPECTED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEGA 2 PLUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>URINOZINC</medicinalproduct>
        <drugindication>POLLAKIURIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569301-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943042-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569302-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930138-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.738</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40 AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569303-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910038-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569304-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120615</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946871-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569305-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909364-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569306-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120530</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0940948-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569307-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896875-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120118</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569308-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901027-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PYREXIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>POTENTIATING DRUG INTERACTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120119</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SALMON OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569309-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896378-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>68</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN JAW</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAXIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NTG SL</medicinalproduct>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120108</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIPSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMDUR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZAROXOLYN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROGLYCERIN</medicinalproduct>
        <drugdosagetext>PATCH</drugdosagetext>
        <drugindication>CHEST PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120105</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG - AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120104</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120109</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROCARDIA XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569310-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120124</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896528-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569311-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0900975-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120128</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYTIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569312-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120123</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0896209-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20061201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569313-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120202</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901149-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569314-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908927-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>13 UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIAL OCCLUSIVE DISEASE</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120223</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569315-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908924-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EXFORGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569316-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942064-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>PATIENT REPORTED HE THINKS HE</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SUGAR PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOODP RESSURE PILL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569317-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909011-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>2 HOURS PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569318-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909330-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569319-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917525-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569320-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941520-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INTUNIV</medicinalproduct>
        <drugdosagetext>2 TO 3MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADDERALL 5</medicinalproduct>
        <drugdosagetext>15 TO 30MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYVANSE</medicinalproduct>
        <drugdosagetext>70MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569321-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908976-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569322-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909010-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569323-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120226</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908939-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRENEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRTAZAPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569324-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909456-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSORY DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120209</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569325-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0946996-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569326-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909339-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120217</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120225</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569327-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120225</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909600-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569328-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941498-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569329-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909416-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20100801</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100801</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569330-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909342-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120220</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569331-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942323-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALFUZOSIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569332-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909653-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENEX</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PERCOCET</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569333-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910002-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY OCCLUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTRA CARE</medicinalproduct>
        <drugdosagetext>OVER THE COUNTER PLANT DERIVATIVE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGA RED</medicinalproduct>
        <drugindication>SUPPLEMENTATION THERAPY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569334-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569335-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941100-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>64.468</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CAROTID ARTERY OCCLUSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569336-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909999-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugdosagetext>TAKE 30 MINUTES BEFORE NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569337-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909837-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.002</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MIN PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569338-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942889-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569339-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941030-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569340-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910212-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.266</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED BP MEDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569341-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909898-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.886</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569342-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942132-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120504</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>MONDAY, WEDNESDAY, FRIDAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569343-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931860-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569344-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569345-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942131-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>X2 DOSES</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569346-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931789-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugindication>PSORIATIC ARTHROPATHY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADALIMUMAB</medicinalproduct>
        <drugindication>PSORIASIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110801</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANXIETY MEDICATION</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>DIURETIC THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569347-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942320-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569348-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120228</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909452-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DERMAL CYST</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>1200 MG THREE TIMES A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugdosagetext>50 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugdosagetext>? MG MONTHLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugdosagetext>2 TABS THREE TIMES DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugdosagetext>2 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>50 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG AT BEDTIME, PREMEDICATION FOR NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugdosagetext>50 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugdosagetext>135 MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>75 MCG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugdosagetext>?MEQ DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMILORIDE HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>5 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACTRIM</medicinalproduct>
        <drugindication>DERMAL CYST</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569349-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906165-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GARLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569350-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942984-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569351-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909366-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIALDA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZATHIOPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 X 2 TABS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>REMICADE</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569352-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930064-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAD INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugindication>HEART RATE IRREGULAR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569353-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHENOPIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>5MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569354-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906534-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20010101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIOVASCULAR EVENT PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569355-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906235-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.462</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569356-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930003-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569357-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906416-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QHS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569358-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906174-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569359-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.07</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569360-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906289-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569361-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930005-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TENORMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY IN AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>88MCG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569362-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910015-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.254</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120228</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569363-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943392-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569364-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906785-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569365-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906234-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569366-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898110-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METANEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASTEPRO</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120123</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVAMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BROMIDE+ALBUTEROL NEBULIZER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QVAR 40</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMCINOLONE</medicinalproduct>
        <drugadministrationroute>045</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569367-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910410-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RENAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>KIDNEY INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MACROBID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569368-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943548-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569369-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906665-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TINNITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TWO UNKNOWN BLOOD PRESSURE MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LAVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569370-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906164-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA/HX (PATIENT SPELLED IT)</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569371-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943204-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>VITAMIN B12 DEFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MAGNESIUM HYDROXIDE TAB</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugdosagetext>30 MINUTES BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID AC</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569372-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120229</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910019-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>47.216</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugdosagetext>0.125 MG 1 TAB DAILY IN THE MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUGH SYRUP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugdosagetext>1 TAB TWICE WEEKLY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NITROFURANTOIN</medicinalproduct>
        <drugdosagetext>1 TAB AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120222</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUVIA</medicinalproduct>
        <drugdosagetext>100 MG DAILY WITH LUNCH</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugdosagetext>1000</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OKENCIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugdosagetext>250/50 ONE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569373-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906900-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569374-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906609-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>165.71</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUSCLE RELAXER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BED TIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569375-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120531</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941411-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>HOT FLUSH</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>7</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569376-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906833-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>127.12</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL SUCCINATE EXTENDED RELEASE</medicinalproduct>
        <drugdosagetext>1/2 IN A.M. 1/2 IN P.M.</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugdosagetext>160/4.5</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>10/40MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY EVENING WITH NIASPAN COATED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569377-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906640-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FAMOTIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569378-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906161-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120211</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569379-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906156-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120117</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOXYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569380-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931498-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>133.93</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG WITH DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>100MG 2 AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569381-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931072-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INJECTION SITE PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTENONOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L-CARTINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORODONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG 30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569382-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906634-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120218</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569383-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910375-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XARELTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569384-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906162-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>105.78</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LABORATORY TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARAVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569385-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931554-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SINUS DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120424</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569386-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906855-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMAZAN C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>RENAL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBACORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569387-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941780-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.266</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569388-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906301-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG 2 TABS</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG 1 TAB</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569389-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930963-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME NOT PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569390-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120214</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906904-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOSS OF CONSCIOUSNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569391-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931636-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>40/25 ONCE DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>STENT PLACEMENT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569392-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906291-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF HEAVINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569393-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569394-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932069-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569395-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942392-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.916</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugadministrationroute>055</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VICTOZA</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCIFEX</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENUVIA</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugdosagetext>IN THE EVENING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569396-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930375-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>54.48</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120419</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569397-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906340-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG X2 TABS AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>ARTERIOSCLEROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569398-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931556-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugdosagetext>MONTHLY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>40MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569399-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120602</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941999-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GENERALISED ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569400-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120218</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906662-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ADVERSE DRUG REACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569401-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906861-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>62.198</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ATRIAL FIBRILLATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARTHROTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARATIN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPROL-XL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569402-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931037-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569403-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120601</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941531-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.266</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SALIVARY HYPERSECRETION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CHOLESTEROL INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTOLERANCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2-500MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG INTOLERANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ARTHRALGIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569404-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930388-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569405-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120428</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930380-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AFTER BREAKFAST; ONE AFTER DINNER</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569406-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942517-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569407-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931139-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569408-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931481-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOSORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569409-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569410-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932077-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SENSATION OF BLOOD FLOW</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569411-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120420</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569412-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942507-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569413-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931534-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569414-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930714-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120429</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER CHOLESTEROL MEDICATION</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569415-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898482-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>PRIOR TO NIASPAN DOSE</drugdosagetext>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>ELECTROLYTE SUBSTITUTION THERAPY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569416-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931858-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>AGGRESSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARANOIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOZAPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569417-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931936-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DESEPRAMINE</medicinalproduct>
        <drugindication>IRRITABLE BOWEL SYNDROME</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HORMONE PATCH</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569418-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120213</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898581-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NECK PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FALL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTRIC ULCER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPOUNDED HORMONE REPLACEMENT THERAPY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMPOUNDED T3 AND T4 THYROID HORMONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>BEDTIME; DECREASED 500MG; BACK TO 1000MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569419-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932012-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>78</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569420-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120224</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0908987-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>168.43</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG X 2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569421-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943402-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569422-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929929-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569423-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930041-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569424-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942006-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BALANCE DISORDER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120603</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPANOLOL ER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXALANT ER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569425-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930006-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.824</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>TOOTH INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PENICILLIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120403</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569426-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909196-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120224</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120225</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569427-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898126-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569428-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906124-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.438</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ANXIETY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569429-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942436-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569430-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909338-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>102.15</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569431-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943399-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>ONE IN MORNING AND ONE IN NIGHT</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569432-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930363-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH ERYTHEMATOUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLONOPIN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569433-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120731</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-GILEAD-2012-0059088</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DEATH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LETAIRIS</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111202</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569434-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942903-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569435-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120717</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>JP-GILEAD-2012-0058759</companynumb>
    <primarysource>
      <reportercountry>JAPAN</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCODYNE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110130</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>022081</drugauthorizationnumb>
        <drugdosagetext>5 MG, QD</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101214</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110108</drugenddate>
        <drugtreatmentduration>25</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>30 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110205</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110210</drugenddate>
        <drugtreatmentduration>6</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>10 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101230</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110120</drugenddate>
        <drugtreatmentduration>21</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>0.6 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101212</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110127</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER                             /00706001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101217</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HEPARIN</medicinalproduct>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101211</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110114</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>7 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101220</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101230</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>5 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101216</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101220</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AMBRISENTAN</medicinalproduct>
        <drugauthorizationnumb>22081</drugauthorizationnumb>
        <drugdosagetext>7.5 UNK, UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110109</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTOMOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS AGAINST DIARRHOEA</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110127</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110812</drugenddate>
        <drugtreatmentduration>196</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>OSTEOPOROSIS PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ADCIRCA</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEPAS</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ANXIETY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICON                            /00048102/</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>COUGH</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110117</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110130</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFAMETHOXAZOLE AND TRIMETHOPRIM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INFECTION PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110224</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>3 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101212</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
        <drugtreatmentduration>5</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GASTER                             /00706001/</medicinalproduct>
        <drugdosagetext>UNK</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20101216</drugenddate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>32 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugindication>PULMONARY ARTERIAL HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110210</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>28 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110204</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110205</drugenddate>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOLAN</medicinalproduct>
        <drugdosagetext>20 NG/KG/MIN</drugdosagetext>
        <drugadministrationroute>042</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110120</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110204</drugenddate>
        <drugtreatmentduration>14</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WARFARIN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101224</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110124</drugenddate>
        <drugtreatmentduration>35</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569436-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930024-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569437-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929952-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569438-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943401-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569439-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120227</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0909367-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT NOON</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569440-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930008-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>71.732</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>3 TABS X 1000MG DAILY= 3000MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120423</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugdosagetext>20MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>2000MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM WITH VITAMIN D AND K</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569441-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943388-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.95</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569442-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906285-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569443-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120429</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930359-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO NIASPAN COATED DOSE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREMARIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYMBICORT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120427</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREVACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569444-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120529</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941653-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPEPSIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FAECES PALE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>THYROID DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EYE DROPS</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASAL SPRAY</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569445-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120604</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942138-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.352</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD TRIGLYCERIDES ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569446-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931118-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120320</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AVODART</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDURA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569447-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932066-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569448-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930391-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569449-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932020-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DECYCLOMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DETROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569450-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931106-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugdosagetext>3 TIMES DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>LIPOPROTEIN (A) ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120430</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRADIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569451-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898444-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>75.818</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569452-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931186-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569453-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931520-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABNORMAL DREAMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRY MOUTH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THROMBOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG-1/2 IN AM, 1/2 IN PM</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN THE MORNING</drugdosagetext>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STRESS B COMPLEX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXYN SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BACK PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ONE A DAY</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569454-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942393-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569455-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930470-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAPABENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569456-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120221</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906901-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RENAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>2-81MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>500C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINAMMON</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20111228</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569457-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932000-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569458-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931510-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.444</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569459-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931567-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MICTURITION URGENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TREMOR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING OF BODY TEMPERATURE CHANGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>DRUG THERAPY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120428</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569460-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120603</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0941832-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG X 2</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROXINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISOMETH/APAP/PICHLOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYZAAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEGAMEN 50 VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPIRAMATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569461-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912497-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>OEDEMA PERIPHERAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569462-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931500-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORATADINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569463-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912335-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569464-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912172-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569465-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931547-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>84.898</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIGRAINE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYSINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569466-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912348-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569467-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918026-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20050301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569468-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912359-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120214</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569469-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931608-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569470-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918014-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>76.272</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B COMPLEX CAP</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569471-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918025-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.018</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MUSCLE RELAXANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENONOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIZIPAM</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569472-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918062-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEART RATE IRREGULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ISORBIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569473-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931788-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>44.946</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569474-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943590-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERSENSITIVITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569475-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932408-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20050502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569476-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912882-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.106</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUVITE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569477-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-VERTEX PHARMACEUTICALS INC.-AE-2012-011196</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>52.2</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DEHYDRATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMOGLOBIN DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEGASYS</medicinalproduct>
        <drugadministrationroute>058</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>INCIVEK</medicinalproduct>
        <drugbatchnumb>244049</drugbatchnumb>
        <drugauthorizationnumb>201917</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RIBASPHERE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEPATITIS C</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120507</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569478-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918408-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569479-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120324</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918350-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569480-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917983-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>101.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN (ALEVE)</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE SUBSTITUTE IN FD</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569481-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931939-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120502</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569482-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912891-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH MACULAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING COLD</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>LDL/HDL RATIO</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120108</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569483-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918542-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>PILLS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100930</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL ARTHRITIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CITRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569484-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932269-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>LIVER DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>WILL ADVANCE TO 1000MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569485-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911878-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>49.94</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120303</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM OXIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTAQ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROPRANOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LITHIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OSTEO BI-FLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569486-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120426</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0929930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120405</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569487-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898446-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.536</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120124</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALTACE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569488-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120727</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2011-BP-28907BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BONE DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN DISCOLOURATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD TEST ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HEART RATE ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENADRYL</medicinalproduct>
        <drugdosagetext>25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>19900101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569489-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943412-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120425</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>X2 PILLS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569490-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910770-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>DEPRESSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOTREL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569491-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912213-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569492-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898464-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>134.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELAXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120116</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLORITHIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569493-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943409-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOE OINTMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT LUNCH, MANUFACTURER SUGGESTED NIASPAN AT BEDTIM</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120605</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569494-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898589-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>128.03</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONIDINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110101</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569495-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912353-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY AFTERNOON</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569496-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911050-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TESTOSTERONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CENTRUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120304</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120304</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569497-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898520-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MUSCULOSKELETAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH HER DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN MEDICATION</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MEDICATION SIMILAR TO LYRICA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569498-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898114-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NAPROXEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUTICASONE PROPIONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALBUTEROL</medicinalproduct>
        <drugdosagetext>INH AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569499-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912751-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>51.756</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIGOXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569500-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898511-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CAFFEINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GAVAPROTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLARINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SENTINEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SKELAXIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NIGHT, 45 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NPH INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569501-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910931-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GAIT DISTURBANCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DISORIENTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING PROJECTILE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569502-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910595-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AZOR</medicinalproduct>
        <drugdosagetext>5/20 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugdosagetext>15 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG IN THE MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20091114</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugdosagetext>2.5 MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugdosagetext>? MG TWICE DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugdosagetext>? MG AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569503-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930015-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GLUCOSE TOLERANCE IMPAIRED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>4 TABS AT NIGHT</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20031101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569504-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912538-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIPHEN-ATROPINE</medicinalproduct>
        <drugindication>DIARRHOEA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VERAPAMIL EXTENDED-RELEASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NABUMETONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRISTIQ</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>ARTHRITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON M20</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOSOTINZICLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569505-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898596-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>85.806</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569506-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910412-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569507-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911112-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, NIGHTLY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569508-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120217</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906106-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>69</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROOESOPHAGEAL REFLUX DISEASE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569509-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910910-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>55.388</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569510-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912527-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>57.658</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITALOPRAM HYDROBROMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTONIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NON-ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OCCUVITE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569511-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910919-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>CHANGED TO 1 TAB</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKING 2 TABS</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569512-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906415-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEAT RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120216</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569513-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911104-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>100.79</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RAMIPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN CENTRUM SILVER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, NIGHTLY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120304</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICINE</medicinalproduct>
        <drugindication>URINARY TRACT INFECTION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569514-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912746-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFEXOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TOPAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLEGRA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120306</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACYCLOVIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569515-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912753-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569516-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911147-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569517-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120220</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0906312-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569518-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911855-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.094</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUS HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VISTARIL</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEXA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569519-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912883-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PNEUMONIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URINARY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569520-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912810-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.076</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MEDICATION RESIDUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569521-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911911-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>74</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SYNCOPE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>INKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569522-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930369-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>61.29</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569523-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943581-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>82.628</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120603</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>META-SITOSTEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRANBERRY</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LYRICA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT 1/2 HOUR AFTER AN ASPIRIN</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120525</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120531</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569524-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912769-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.634</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PREDNISONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR HCT</medicinalproduct>
        <drugdosagetext>20/12.5MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugadministrationroute>060</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569525-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912095-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN PILL</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN PAIN KILLER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569526-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930468-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES DAILY AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569527-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912895-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE + CHONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CITRACAL + D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MINOCYCLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>STAPHYLOCOCCAL INFECTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANDROGEL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569528-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912401-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUMIGAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PILOCARPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUDROCORTISONE ACETATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>MITRAL VALVE DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120223</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEXAPRO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIGAN</medicinalproduct>
        <drugindication>GLAUCOMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOLBIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569529-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120308</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912919-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FAECES DISCOLOURED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LASIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATION WITH NAPROXYN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569530-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CONTUSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569531-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0930386-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569532-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>96.248</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569533-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912775-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY SLEEP</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120215</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569534-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912355-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER NOON MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110901</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN EYE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MONOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569535-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917951-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FOR LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SUPER B COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHROMIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CINNAMON</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20101101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569536-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917958-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>3 TIMES DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAXALONE</medicinalproduct>
        <drugdosagetext>2 TIMES DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ETODOLAC</medicinalproduct>
        <drugdosagetext>400MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569537-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912515-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING AND QHS</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569538-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912139-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569539-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912768-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHONDROITIN W/GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCITRIOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120305</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569540-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912735-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.082</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BUPROPION HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANAFLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugdosagetext>25 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARTIA XT</medicinalproduct>
        <drugdosagetext>240 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TIMOLOL MALEATE</medicinalproduct>
        <drugdosagetext>EVERY AM</drugdosagetext>
        <drugadministrationroute>047</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugdosagetext>1 EVERY 6 HOURS AS REQUIRED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugdosagetext>140 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugdosagetext>AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569541-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918114-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569542-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120322</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918242-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>HIGH DENSITY LIPOPROTEIN ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569543-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910852-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATORVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060301</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569544-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931518-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569545-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932402-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.088</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN NAMES OF OTHER MEDICATIONS NOT REPORTED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569546-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16450BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FACE INJURY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CELLULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>VIRAMUNE</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020636</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569547-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120427</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931726-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120301</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569548-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910888-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>97.61</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VITAMIN D DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EAR DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>SUPPLEMENT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569549-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932062-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SUNBURN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BLOOD PRESSURE MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AROUND 10:00PM AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569550-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942497-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RELIV</medicinalproduct>
        <drugindication>MEDICAL DIET</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FOSAMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569551-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120724</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16480BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS POSTURAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRITIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>MICARDIS</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020850</drugauthorizationnumb>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020579</drugauthorizationnumb>
        <drugdosagetext>0.4 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PROSTATIC DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569552-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898503-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569553-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120508</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932167-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569554-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910877-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SULFASALAZINE</medicinalproduct>
        <drugindication>COLITIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569555-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931536-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.69</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN OVER THE COUNTER MEDICATION</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN DIURETIC MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>BEFORE THE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569556-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943015-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ORAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120602</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569557-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932395-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569558-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessdeath>1</seriousnessdeath>
    <seriousnesslifethreatening>1</seriousnesslifethreatening>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120801</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-DE-01783DE</companynumb>
    <primarysource>
      <reportercountry>GERMANY</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>80</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>CORONARY ARTERY INSUFFICIENCY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMORRHAGIC ANAEMIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RECTAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SHOCK HAEMORRHAGIC</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>DABIGATRAN</medicinalproduct>
        <drugauthorizationnumb>22512</drugauthorizationnumb>
        <drugdosagetext>220 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569559-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898594-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569560-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120504</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932403-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NUVIGIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569561-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910893-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>129.39</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA ORAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, NIGHTLY</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120302</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569562-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120606</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943001-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569563-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931946-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPOFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569564-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898439-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111225</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569565-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16587BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>90</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VESSEL PERFORATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>AGGRENOX</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>020884</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569566-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931541-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>66.284</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIZZINESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VERTIGO</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDERAL</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>MIGRAINE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120430</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ULTIMATE ANTIOXIDANT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME; HELD DOSE OF NIASPAN ON 29 APR 2012</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>B SUPREME</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>N-ACETYL-L-CYSTEINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E COMPLEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569567-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911853-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERUCTATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAXIVISION VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120204</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>QUINAPRIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>4 PRIOR TO NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569568-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0942902-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>THYROID DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 - 500 MG PILLS AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569569-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120501</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931865-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>111.23</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
        <drugtreatmentduration>30</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugtreatmentduration>1</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569570-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910620-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>181.6</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569571-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120725</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16555BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL AND CHLORTHALIDONE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugdosagetext>20 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>40 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>NOT REPORTED</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugdosagetext>300 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMITRIPTYLINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PAIN IN EXTREMITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugdosagetext>100 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>ATRIAL FIBRILLATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569572-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912012-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569573-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120430</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932124-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LETHARGY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HYPERTRIGLYCERIDAEMIA</drugindication>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569574-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120605</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943136-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.162</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BONIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARDIZEM</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM +D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569575-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910604-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569576-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120126</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898465-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CHEST PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MALAISE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UROCIT-K</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONCE DAILY AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569577-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120726</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2012-BP-16615BP</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>85</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MOUTH HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HAEMATURIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>PRADAXA</medicinalproduct>
        <drugbatchnumb>108176</drugbatchnumb>
        <drugauthorizationnumb>022512</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120703</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569578-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnesshospitalization>1</seriousnesshospitalization>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918400-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>146.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 AT BED TIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN COATED</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569579-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918828-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY IN THE MORNING/AFTERNOON</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569580-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947383-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569581-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947412-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EPISTAXIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>WITH THE DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569582-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120203</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901407-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>EYE IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000 UNITS DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>L ZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAX SEED</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569583-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947918-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VOLTAREN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>IN MORNING</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120616</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569584-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952030-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.76</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEAR</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIALLERGIC AGENTS, EXCL CORTICOSTEROIDS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTITHROMBOTIC AGENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569585-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951571-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569586-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923981-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COLD SWEAT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NERVOUSNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD PRESSURE DECREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEART RATE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE BESYLATE AND BENAZEPRIL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569587-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924114-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GENERIC FOR LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>2 UNKNOWN BLOOD PRESSURE PILLS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569588-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912490-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>113.5</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYETTA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569589-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0937535-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569590-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924712-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>RASH PRURITIC</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JENUVIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 TABS AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569591-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120204</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569592-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924160-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>63.56</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RALOXIFENE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569593-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120306</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912351-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICINES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20090101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569594-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0937418-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>TAKES 1 PO AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120517</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569595-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924222-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALAZAPAM</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IMITREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XALATAN</medicinalproduct>
        <drugdosagetext>1 DROP EACH EYE</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569596-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120521</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936954-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>106.24</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL DISORDER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>TYPE 2 DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2-1000MG AT BEDTIME</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20051001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugdosagetext>50MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN ALLERGY SHOT MEDICATION</medicinalproduct>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569597-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903642-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569598-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912761-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569599-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952343-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569600-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924181-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.59</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SCRATCH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLISTER</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAG-OX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STEROID/CORTISONE</medicinalproduct>
        <drugindication>BACK DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INDAPAMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COMBIVENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120406</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN B-12</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FERROUS SULFATE TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569601-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0937532-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569602-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923956-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENALAPRIL MALEATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BARLEY GREEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPOIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDILOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STOOL SOFTENER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COUMADIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METAMUCIL-2</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569603-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120307</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912765-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>109.87</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ENTERIC COATED PROBIOTIC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRANDIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569604-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952311-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG = 2 TABS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCHLOROTHIAZDE TAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIFEDIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1500MG = 3 TABS AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT  BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SOTALOL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569605-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924216-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>65.83</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>DAILY AT VARIOUS TIMES OF DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEURONTIN</medicinalproduct>
        <drugdosagetext>800MG 3-4 TIMES PER DAY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugdosagetext>2000IU</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDRALAZINE HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LABETALOL HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMPYRA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569606-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952256-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEIN SUPPLEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON SUPPLEMENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569607-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924243-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>70.37</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>UNEVALUABLE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PLATELET COUNT DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENASTERIDE</medicinalproduct>
        <drugindication>PROSTATOMEGALY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569608-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943585-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.456</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120607</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569609-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120518</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0936781-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BETABLOCKER</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STRESS MEDICINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569610-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924211-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG, 2 TABS QHS</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG 2 ONCE A DAY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569611-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951572-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569612-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924324-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>67.192</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>TOTAL CHOLESTEROL/HDL RATIO ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20020101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569613-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943583-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120520</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNESTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXEPIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAMADOL HCL</medicinalproduct>
        <drugdosagetext>50</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569614-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120522</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0937970-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HOT FLUSH</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569615-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924805-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALENDRONATE SODIUM</medicinalproduct>
        <drugindication>OSTEOPOROSIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOXETINE HCL</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIOVAN</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>INSOMNIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOC-Q-LAX</medicinalproduct>
        <drugindication>ILL-DEFINED DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORAZEPAM</medicinalproduct>
        <drugindication>PANIC ATTACK</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALVESCO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRIVA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FORADIL</medicinalproduct>
        <drugindication>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569616-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120630</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951938-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120629</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569617-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924207-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SINUSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VYTORIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENAZEPRIL HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MUCINEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVEMIR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569618-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948255-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569619-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947479-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>110.32</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>LOWER RESPIRATORY TRACT INFECTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CARVEDIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569620-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947995-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>120.31</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD SUGAR MEDICATION</medicinalproduct>
        <drugindication>BLOOD GLUCOSE ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZINC SULFATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>WEIGHT INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>CORONARY ARTERY BYPASS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASCORBIC ACID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569621-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918748-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYANOCOBALAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VIT C</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACCUPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20090101</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUTEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569622-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947785-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DIVERTICULITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>INTERVERTEBRAL DISC PROTRUSION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT 7:00 TO 7:30 AM</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WOMEN'S MULTI</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GINGKO BILOBA EXTR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROTEINS NOS W/VITAMINS NOS</medicinalproduct>
        <drugindication>NAIL DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569623-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932280-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PALPITATIONS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569624-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918971-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugdosagetext>20MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>8AMG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20070101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569625-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120204</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0901415-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG, 3 TABLETS AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PEPCID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569626-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947767-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569627-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120127</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898593-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURSITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ARTHRALGIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NASONEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOTREXATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIPIZIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DICLOFENAC SODIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LANTUS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569628-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120328</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0919268-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.794</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>CONSTIPATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>GASTROINTESTINAL SOUNDS ABNORMAL</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SOMNOLENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASTHENIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EXTENDED RELEASE, TAKING IT AT NIGHT</drugdosagetext>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569629-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948263-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SAW PALMETTO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED ORAL DIABETES MEDICATION</medicinalproduct>
        <drugdosagetext>DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569630-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948502-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL PAIN UPPER</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DEXILANT</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120606</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRAZODONE HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569631-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0919170-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>ASTHMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>APHASIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCLE SPASMS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NASOPHARYNGITIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MEMORY IMPAIRMENT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOPENEX</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IRON</medicinalproduct>
        <drugindication>ANAEMIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SINGULAIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE CONDROITIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADVIR</medicinalproduct>
        <drugindication>ASTHMA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RESTASIS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLONASE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTRACE</medicinalproduct>
        <drugindication>URETHRITIS NONINFECTIVE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugtreatmentduration>8</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZANTAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569632-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948290-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISTENSION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MUSCULAR WEAKNESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG-TWO AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNSPECIFIED GERD MEDICATION</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOSAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELADRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569633-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948185-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110126</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120601</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN SUPPLEMENTS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569634-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910612-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569635-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120209</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0903646-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569636-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947754-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120611</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME FOR ONE WEEK</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120604</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120610</drugenddate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569637-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948280-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>92.616</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SKIN IRRITATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FORMICATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID TAB</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GUANFACINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAQUENIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>EFFIENT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110701</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACETYLSALICYLIC ACID ENTERIC COATED</medicinalproduct>
        <drugindication>FLUSHING</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500MG HS</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110701</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>JANUMET</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569638-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910926-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN OF SKIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569639-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947422-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES BEFORE NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL PM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120618</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MAGNESIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569640-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947761-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>CORONARY ARTERY DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIGOUT PREPARATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569641-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120410</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0923952-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120330</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>STATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569642-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120302</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910876-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569643-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947750-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569644-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947797-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>90.8</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUMETZA</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569645-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924700-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>73.548</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BP MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRILOSEC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569646-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120412</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924677-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>WHEEZING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>OESOPHAGEAL PAIN</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLERGY MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569647-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120301</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0910906-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>POOR QUALITY DRUG ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>WRONG TECHNIQUE IN DRUG USAGE PROCESS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>CUT TABLET IN HALF</drugdosagetext>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120218</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120218</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120213</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120217</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569648-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947794-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DISTURBANCE IN ATTENTION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING ABNORMAL</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MIRAPEX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>WELLBUTRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120617</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COPAXONE</medicinalproduct>
        <drugadministrationroute>050</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>VITAMIN D DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROZAC</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569649-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947921-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>60.836</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>LIPIDS INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ASPARTATE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ALANINE AMINOTRANSFERASE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD CALCIUM DECREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 - 750MG TABLETS DAILY FOR A FEW DOSES</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>LIPIDS INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIOTIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPOPROTEIN (A) INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569650-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924705-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.972</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugdosagetext>2000 MG DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000MG X 2 EVERY A.M. AND 2 EVERY P.M.</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG (PRIOR TO TAKING NIASPAN DOSE IN A.M.)</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1000 MG X 2 DAILY</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569651-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924254-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.02</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PAIN IN EXTREMITY</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FATIGUE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BACK PAIN</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN POTASSIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PROMETHAZINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATENOLOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569652-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120305</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911922-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>500 MG, 1/2 IN AM AND 1/2 IN PM</drugdosagetext>
        <drugindication>CEREBROVASCULAR ACCIDENT</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COLESTIPOL HYDROCHLORIDE</medicinalproduct>
        <drugdosagetext>AT 10 AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EACH MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569653-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948278-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 DAY, AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569654-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951573-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20080601</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ACTOS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569655-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120411</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0924646-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>SWELLING FACE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN WARM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>CHILLS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LIPIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120410</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569656-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947847-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>89.892</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HYPOTHYROIDISM</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NIACIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SYNTHROID</medicinalproduct>
        <drugindication>HYPOTHYROIDISM</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20040719</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROVEN</medicinalproduct>
        <drugdosagetext>OTC, 2 IN 1 DAYS</drugdosagetext>
        <drugindication>HYSTERECTOMY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORVASC</medicinalproduct>
        <drugindication>BLOOD PRESSURE INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>CARDIAC DISORDER</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COQ10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569657-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0912288-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLATULENCE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BYSTOLIC</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLOPIDOGREL BISULFATE</medicinalproduct>
        <drugindication>THROMBOSIS PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PROPHYLAXIS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ARICEPT</medicinalproduct>
        <drugindication>AMNESIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SPIRONOLACTONE</medicinalproduct>
        <drugindication>FLUID RETENTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MOBIC</medicinalproduct>
        <drugindication>PAIN</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HUMALOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PAROXETINE</medicinalproduct>
        <drugindication>ANXIETY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110201</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110301</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110201</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20110501</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugdosagetext>BED TIME</drugdosagetext>
        <drugindication>BENIGN PROSTATIC HYPERPLASIA</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NOVOLOG</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569658-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952034-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>99.88</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>POLLAKIURIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPERHIDROSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIVALO</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120621</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LEVOTHYROXINE SODIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569659-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120621</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948365-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>112.14</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBONAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HYDROCODONE BITARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CEPHALEXIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XFORGE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>KLOR-CON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SERTRALINE HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OXYCONTIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120619</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FUROSEMIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569660-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120620</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0948126-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>79.45</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>GOUT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugtreatmentduration>2</drugtreatmentduration>
        <drugtreatmentdurationunit>803</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>HYPERTENSION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>GOUT</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569661-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120619</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947802-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>58.112</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110401</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569662-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120303</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0911462-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.1</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>URTICARIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, EVERY NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120227</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLEXERIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMARIX</medicinalproduct>
        <drugdosagetext>15 MG X 1-2 TABLETS EVERY 6 PM</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NORCO</medicinalproduct>
        <drugdosagetext>10/325 MG 3 X A DAY AND AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>1 IN 1 D, EVERY NIGHT</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DIAZEPAM</medicinalproduct>
        <drugdosagetext>5 MG 3 X A DAY AND AS NEEDED</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569663-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>1</serious>
    <seriousnessother>1</seriousnessother>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120723</receiptdate>
    <fulfillexpeditecriteria>1</fulfillexpeditecriteria>
    <companynumb>US-ELI_LILLY_AND_COMPANY-US201207007315</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>EXFOLIATIVE RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INEFFECTIVE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GABAPENTIN</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>CYMBALTA</medicinalproduct>
        <drugauthorizationnumb>021427</drugauthorizationnumb>
        <drugdosagetext>UNK</drugdosagetext>
        <drugindication>BACK PAIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SEROQUEL</medicinalproduct>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569664-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120330</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918200-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VIITH NERVE PARALYSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HYPOAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120316</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120316</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GEMFIBROZIL</medicinalproduct>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BIRTH CONTROL PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569665-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918342-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>95.34</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>MYALGIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20111001</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>NEXIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>RED YEAST RICE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569666-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932361-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTAPRAZOLE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120426</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZIAC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TAMSULOSIN HCL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMBIEN</medicinalproduct>
        <drugdosagetext>1/2 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZYRTEC</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569667-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917950-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.296</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>DYSPNOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ESTROGEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>THYROID MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRICOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569668-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918445-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>94.432</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>POTASSIUM</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTIVITAMIN WITHOUT IRON</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>750MG X 2 AT BED TIME=1500MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FINASTERIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORTHALIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DOXAZOSIN MESYLATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHLORATAB</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HYPERSENSITIVITY</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569669-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918116-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>118.04</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLOFT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLOMAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D3</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>AT NIGHT, TAKES WITH NIASPAN</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569670-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918337-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINS PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>DRUG HYPERSENSITIVITY</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120203</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569671-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918069-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>COUGH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>EVERY MORNING</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569672-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932171-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.53</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>3 MONTHS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
        <drugtreatmentduration>3</drugtreatmentduration>
        <drugtreatmentdurationunit>802</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ANTIHISTAMINES</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569673-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120325</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918756-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientonsetage>47</patientonsetage>
      <patientonsetageunit>801</patientonsetageunit>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
        <drugtreatmentduration>4</drugtreatmentduration>
        <drugtreatmentdurationunit>804</drugtreatmentdurationunit>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>IBUPROFEN (ADVIL)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPRESSOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569674-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918552-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>74.91</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VOMITING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ABDOMINAL DISCOMFORT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BED TIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MELOXICAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569675-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918363-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>59.928</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM CARBONATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CHOLESTYRAMINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569676-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918065-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>HEADACHE</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugdosagetext>1/2</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120321</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALPHA LIPID ACID</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>MUSCLE SPASMS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LECITHIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LUNG ESSENTIAL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>DRUG INTOLERANCE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81 MG, EVERY MORNING</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569677-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931930-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>83.99</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>NEPHROLITHIASIS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOLPIDEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METHOCARBAMOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CELEBREX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CLONAZEPAM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LORTAB</medicinalproduct>
        <drugdosagetext>7/500MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BACLOFEN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CYCLOBENZAPRINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120414</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569678-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918839-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>104.42</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>81MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugdosagetext>1QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ATACAND HCT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OMEPRAZOLE</medicinalproduct>
        <drugdosagetext>1QD</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLYBURIDE</medicinalproduct>
        <drugdosagetext>TWICE DAILY</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20030201</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569679-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918921-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>93.524</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT NIGHT</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569680-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918430-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>3</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIABETES MELLITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLUCOPHAGE</medicinalproduct>
        <drugindication>DIABETES MELLITUS</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZESTRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugtreatmentduration>10</drugtreatmentduration>
        <drugtreatmentdurationunit>801</drugtreatmentdurationunit>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569681-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918549-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>10MG</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120201</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TYLENOL (CAPLET)</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALTRATE + D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569682-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120503</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0932364-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>78.542</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120407</drugstartdate>
        <drugenddateformat>102</drugenddateformat>
        <drugenddate>20120502</drugenddate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>D LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>COREG</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569683-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947388-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>INSOMNIA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS GENERALISED</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZOCOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN E</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CO Q 10</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CALCIUM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>FREE FATTY ACIDS ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120615</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ADEROL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569684-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0919249-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569685-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918896-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>HIGH BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569686-4</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120125</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0898131-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>86.26</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FENOFIBRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569687-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947405-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>77.18</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569688-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0919221-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>68.554</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>INSULIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOPID</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>2 PILLS</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569689-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918067-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>98.518</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ALLOPURINOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>750MGX2 TABS=1500MG</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>XANAX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569690-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918946-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>88.984</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>GLIMEPIRIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LISINOPRIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MVT</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SODIUM CHLORIDE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL ABNORMAL</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120326</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PRAVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569691-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931599-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>208.84</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN TIGHTNESS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20100501</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN BLOOD PRESSURE MEDICATION</medicinalproduct>
        <drugindication>BLOOD PRESSURE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>UNKNOWN WATER PILL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569692-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120618</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0947774-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>108.96</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>VAGINAL HAEMORRHAGE</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>30 MINUTES PRIOR TO DOSE OF NIASPAN</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METFORMIN HYDROCHLORIDE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569693-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120327</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0919257-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>72.64</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PROPHYLAXIS</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>M.V.I.</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PANTOPRAZOLE</medicinalproduct>
        <drugindication>GASTROOESOPHAGEAL REFLUX DISEASE</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569694-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120325</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918782-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>1</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <reaction>
        <reactionmeddrapt>ADVERSE EVENT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>DRUG INTERACTION</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>3</drugcharacterization>
        <medicinalproduct>RIFAMPIN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569695-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120326</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0918879-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.75</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BLOOD GLUCOSE INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SKIN BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>VITAMIN D</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMIN</medicinalproduct>
        <drugindication>VITAMIN SUPPLEMENTATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ZETIA</medicinalproduct>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110101</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569696-7</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120502</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0931604-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>56.296</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>INCORRECT DOSE ADMINISTERED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD CHOLESTEROL INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569697-9</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943851-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>OTHER UNKNOWN MEDICATIONS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>1 IN 1 D, AT BEDTIME</drugdosagetext>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110601</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569698-0</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120629</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0951940-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>SIMVASTATIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>BENICAR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRIAMTERENE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569699-2</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943588-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PARAESTHESIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>WELCHOL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120530</drugstartdate>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569700-6</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120527</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0937480-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>91.708</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>DIARRHOEA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>RASH</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>NAUSEA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FISH OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT BEDTIME</drugdosagetext>
        <drugindication>HIGH DENSITY LIPOPROTEIN DECREASED</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20120519</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>LOW DENSITY LIPOPROTEIN INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLUOREXITINE</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>TRILIPIX</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>FLAXSEED OIL</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569701-8</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120607</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0943596-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC ENZYME INCREASED</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FEELING HOT</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>SLEEP APNOEA SYNDROME</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>HEPATIC STEATOSIS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>ERYTHEMA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20110301</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>SIMCOR</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>022078</drugauthorizationnumb>
        <drugdosagetext>1000MG/20MG</drugdosagetext>
        <drugindication>BLOOD TRIGLYCERIDES INCREASED</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOVAZA</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569702-X</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120117</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0895008-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569703-1</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120323</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0917977-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>81.72</patientweight>
      <patientsex>2</patientsex>
      <reaction>
        <reactionmeddrapt>BURNING SENSATION</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>PRURITUS</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LOSARTAN/HYDROCHLOORTHIAZIDE</medicinalproduct>
        <drugdosagetext>100/25 MG</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AFTER EVENING MEAL</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
        <drugstartdateformat>102</drugstartdateformat>
        <drugstartdate>20060101</drugstartdate>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>LIPITOR</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>IN AM</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>METOPROLOL TARTRATE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>AMLODIPINE</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>PLAVIX</medicinalproduct>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569704-3</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120702</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952248-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientweight>69.008</patientweight>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>FAMILIAL RISK FACTOR</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>CRESTOR</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugindication>MYOCARDIAL INFARCTION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>DILTIAZEM</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>MULTI-VITAMINS</medicinalproduct>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</drugindication>
      </drug>
    </patient>
  </safetyreport>
  <safetyreport>
    <safetyreportid>8569705-5</safetyreportid>
    <transmissiondateformat>102</transmissiondateformat>
    <transmissiondate>20120928</transmissiondate>
    <serious>2</serious>
    <receivedateformat>102</receivedateformat>
    <receivedate>20120803</receivedate>
    <receiptdateformat>102</receiptdateformat>
    <receiptdate>20120703</receiptdate>
    <fulfillexpeditecriteria>2</fulfillexpeditecriteria>
    <companynumb>US-ABBOTT-12P-163-0952246-00</companynumb>
    <primarysource>
      <reportercountry>UNITED STATES</reportercountry>
      <qualification>5</qualification>
    </primarysource>
    <sender>
      <senderorganization>FDA-Public Use</senderorganization>
    </sender>
    <receiver></receiver>
    <patient>
      <patientsex>1</patientsex>
      <reaction>
        <reactionmeddrapt>FLUSHING</reactionmeddrapt>
      </reaction>
      <reaction>
        <reactionmeddrapt>MIDDLE INSOMNIA</reactionmeddrapt>
      </reaction>
      <drug>
        <drugcharacterization>1</drugcharacterization>
        <medicinalproduct>NIASPAN</medicinalproduct>
        <drugbatchnumb>UNKNOWN</drugbatchnumb>
        <drugauthorizationnumb>020381</drugauthorizationnumb>
        <drugdosagetext>AT MEALTIME</drugdosagetext>
      </drug>
      <drug>
        <drugcharacterization>2</drugcharacterization>
        <medicinalproduct>ASPIRIN</medicinalproduct>
        <drugdosagetext>ONE AT BEDTIME</drugdosagetext>
        <drugadministrationroute>048</drugadministrationroute>
        <drugindication>PRODUCT USED FOR UNKNOWN INDICATION</dr